Surgical Stylet Suppliers
Limit companies to: Worldwide USA
Cooper Surgical, Inc. | Address: 95 Corporate Drive, Trumbul, Connecticut 06611, USA 
www.coopersurgical.com | Send Inquiry | Phone: +001-(203)-601-5200
FDA Registration: 1216677 Year Established: 1990 Annual Revenues: USD 100-500 Million Employee Count: ~430 Quality: ISO 9001, CE Certified
Products: Colposcopes, Disposable Examination Gloves, Vaginal Retractors (FDA Code: HDL), Probes (FDA Code: HXB), Incubators, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Cooper Surgical, Inc. provides medical devices and procedure solutions that improve health care delivery to women regardless of the clinical setting. Our product categories are obstetrics, family plan more...
www.coopersurgical.com | Send Inquiry | Phone: +001-(203)-601-5200
FDA Registration: 1216677 Year Established: 1990 Annual Revenues: USD 100-500 Million Employee Count: ~430 Quality: ISO 9001, CE Certified
Products: Colposcopes, Disposable Examination Gloves, Vaginal Retractors (FDA Code: HDL), Probes (FDA Code: HXB), Incubators, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Cooper Surgical, Inc. provides medical devices and procedure solutions that improve health care delivery to women regardless of the clinical setting. Our product categories are obstetrics, family plan more...
Medtronic Xomed Surgical Products, Inc | Address: 6743 Southpoint Drive North, Jacksonville, Florida 32216-0980, USA
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Sinus Trochars and Cannulae, Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Navigation Interface/Display, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Sinus Trochars and Cannulae, Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Navigation Interface/Display, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
ISPG | Address: 10504 Technology Terrace, Lakewood Ranch, Florida 34211, USA
https://www.ispg.com | Send Inquiry | Phone: +1-(941)-896-3999
FDA Registration: 1221435 Annual Revenues: USD 10-25 Million Employee Count: ~20
Products: Hypodermic Syringes, Glass Syringes, Reusable, Hypodermic Syringes, Reusable, Reusable Glass Syringes, Disposable Glass Syringes, Disposable Hypodermic Syringes, ...
ISPG® supplies bulk custom ground stainless steel, small diameter stainless steel tubular components, glass syringes and custom procedure needles for both medical device & pharmaceutical industrie more...
https://www.ispg.com | Send Inquiry | Phone: +1-(941)-896-3999
FDA Registration: 1221435 Annual Revenues: USD 10-25 Million Employee Count: ~20
Products: Hypodermic Syringes, Glass Syringes, Reusable, Hypodermic Syringes, Reusable, Reusable Glass Syringes, Disposable Glass Syringes, Disposable Hypodermic Syringes, ...
ISPG® supplies bulk custom ground stainless steel, small diameter stainless steel tubular components, glass syringes and custom procedure needles for both medical device & pharmaceutical industrie more...
Vyaire Medical, Inc. | Address: 26125 North Riverwoods Blvd, Mettawa, Illinois 60045, USA
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Fetal Monitors, Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Hematology Analyzers, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l more...
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Fetal Monitors, Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Hematology Analyzers, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l more...
Luxtec | Address: 99 Hartwell Street, West Boylston, Maryland 01583, USA
www.luxtec.com | Send Inquiry | Phone: +1-(508)-835-9700
Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Light Sources, Visual Acuity Charts (FDA Code: HOX), Surgical Headlights, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito more...
www.luxtec.com | Send Inquiry | Phone: +1-(508)-835-9700
Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Light Sources, Visual Acuity Charts (FDA Code: HOX), Surgical Headlights, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito more...
Blackstone Medical, Inc. | Address: 90 Brookdale Drive, Springfield, Massachusetts 01104, USA
www.blackstonemedical.com | Send Inquiry | Phone: +1-(413)-731-8711
Annual Revenues: USD 10-25 Million Employee Count: ~20 Quality: CE Certified
Products: Probes (FDA Code: HXB), Posterior, Plating Systems, Arthroscopes (FDA Code: HRX), Bone Rasps (FDA Code: HTR), Bio Absorbable Plating Systems, ...
Blackstone Medical Inc. produces surgical instruments and devices used in back surgery. Our ascent poct system provides surgeons with means to address complicated fusion cases from the base of the sku more...
www.blackstonemedical.com | Send Inquiry | Phone: +1-(413)-731-8711
Annual Revenues: USD 10-25 Million Employee Count: ~20 Quality: CE Certified
Products: Probes (FDA Code: HXB), Posterior, Plating Systems, Arthroscopes (FDA Code: HRX), Bone Rasps (FDA Code: HTR), Bio Absorbable Plating Systems, ...
Blackstone Medical Inc. produces surgical instruments and devices used in back surgery. Our ascent poct system provides surgeons with means to address complicated fusion cases from the base of the sku more...
Bausch & Lomb | Address: 1400 N. Goodman St., Rochester, New York 14609, USA
www.bausch.com | Send Inquiry | Phone: +1-(585)-338-6000, 800-553-5340
FDA Registration: 1920664 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Lacrimal Dilators and Cannulas, Intraocular Lens Manipulators, Phacoemulsification Systems, Dressing Forceps, Tissue Forceps, Intraocular Lens Forceps, ...
Bausch & Lomb is the eye health company dedicated to perfecting vision and enhancing life. We offer a comprehensive portfolio of eye health products. Our three broad categories of products are vision more...
www.bausch.com | Send Inquiry | Phone: +1-(585)-338-6000, 800-553-5340
FDA Registration: 1920664 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Lacrimal Dilators and Cannulas, Intraocular Lens Manipulators, Phacoemulsification Systems, Dressing Forceps, Tissue Forceps, Intraocular Lens Forceps, ...
Bausch & Lomb is the eye health company dedicated to perfecting vision and enhancing life. We offer a comprehensive portfolio of eye health products. Our three broad categories of products are vision more...
Teleflex Medical | Address: PO Box 12600, Research Triangle Park, North Carolina 27709, USA
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Medical Humidifiers, Oxygen Masks (FDA Code: BYG), Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Medical Humidifiers, Oxygen Masks (FDA Code: BYG), Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
Conmed Integrated Systems | Address: 1815 NW 169th Place, Suite 4020, Beaverton, Oregon 97006, USA
www.conmed.com/IntegratedSystems_newdesign.php | Send Inquiry | Phone: +1-(503)-614-1106
Products: Cables, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Tubing, Integrated OR Systems, Catheters, ...
Conmed Integrated Systems provides technology and service for the medical environment. We design completely integrated surgical suites and other patient critical care environments. We offer products l more...
www.conmed.com/IntegratedSystems_newdesign.php | Send Inquiry | Phone: +1-(503)-614-1106
Products: Cables, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Tubing, Integrated OR Systems, Catheters, ...
Conmed Integrated Systems provides technology and service for the medical environment. We design completely integrated surgical suites and other patient critical care environments. We offer products l more...
Aesculap Inc. | Address: 3773 Corporate Parkway, Center Valley, Pennsylvania 18034, USA
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Vaginal Retractors (FDA Code: HDL), Curettes, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Vaginal Retractors (FDA Code: HDL), Curettes, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
Orthovita | Address: 77 Great Valley Parkway, Malvern, Pennsylvania 19355, USA
www.orthovita.com | Send Inquiry | Phone: +1-(610)-640-1775
FDA Registration: 2530131 Year Established: 1992
Products: Hydroxyapatite Orbital Implants, Synthetic Spacers, Hydroxyapatite, Biopsy Instruments (FDA Code: KNW), Artificial Hydroxyapatite Orbital Implant, Bio-Eyes Hydroxyapatite Orbital Implant, ...
Orthovita is a biomaterials company with proprietary technologies applied to the development of biostructures. We focus on novel products for use in spine surgery and in the repair of osteoporotic fra more...
www.orthovita.com | Send Inquiry | Phone: +1-(610)-640-1775
FDA Registration: 2530131 Year Established: 1992
Products: Hydroxyapatite Orbital Implants, Synthetic Spacers, Hydroxyapatite, Biopsy Instruments (FDA Code: KNW), Artificial Hydroxyapatite Orbital Implant, Bio-Eyes Hydroxyapatite Orbital Implant, ...
Orthovita is a biomaterials company with proprietary technologies applied to the development of biostructures. We focus on novel products for use in spine surgery and in the repair of osteoporotic fra more...
Synthes, Inc. | Address: 1302 Wrights Lane East, West Chester, Pennsylvania 19380, USA
us.synthes.com | Phone: +1-(610)-719-5000, 800 523 0322
FDA Registration: 2939274
Products: Hydroxyapatite Orbital Implants, Demineralized Bone Matrix, Hydroxyapatite, Resorbable Plating Systems, Disc Replacements, Femoral IM Nails, ...
Synthes, Inc. develops market instruments, implants and biomaterials for the surgical fixation, correction and regeneration of the skeleton and its soft tissues. We develop & market instruments, impla more...
us.synthes.com | Phone: +1-(610)-719-5000, 800 523 0322
FDA Registration: 2939274
Products: Hydroxyapatite Orbital Implants, Demineralized Bone Matrix, Hydroxyapatite, Resorbable Plating Systems, Disc Replacements, Femoral IM Nails, ...
Synthes, Inc. develops market instruments, implants and biomaterials for the surgical fixation, correction and regeneration of the skeleton and its soft tissues. We develop & market instruments, impla more...
Smith & Nephew Inc. | Address: 1450 Brooks Road, Memphis, Tennessee 38116, USA
www.smith-nephew.com | Phone: +1-(901)-399-2121, 800-821-5700
Annual Revenues: USD 50-100 Million Employee Count: ~400 Quality: ISO 9001 Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Fixation Forceps, Tissue Forceps, Kremer Fixation Forceps, Double Prong Skin Hooks, ...
Smith & Nephew is a wound care management company that manufactures and supplies medical products for the diagnosis of wound care management. Our products & services for wound, skin, IV, & burn care i more...
www.smith-nephew.com | Phone: +1-(901)-399-2121, 800-821-5700
Annual Revenues: USD 50-100 Million Employee Count: ~400 Quality: ISO 9001 Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Fixation Forceps, Tissue Forceps, Kremer Fixation Forceps, Double Prong Skin Hooks, ...
Smith & Nephew is a wound care management company that manufactures and supplies medical products for the diagnosis of wound care management. Our products & services for wound, skin, IV, & burn care i more...
Orthofix Inc. | Address: 1720 Bray Central Drive, McKinney, Texas 75069, USA
www.orthofix.com | Send Inquiry | Phone: +1-(469)-742-2500, 800-535-4492
FDA Registration: 2183449 Year Established: 1980 Employee Count: ~200 Quality: ISO Certified
Products: Probes (FDA Code: HXB), Femoral IM Nails, Ankle External Fixators, Elbow External Fixators, Hand External Fixators, Static External Fixators, ...
Orthofix Inc. designs, manufactures & distributes medical equipment, mainly for the orthopedic market. Our orthopedics, spine and sports medicine divisions offer innovative treatment options for adult more...
www.orthofix.com | Send Inquiry | Phone: +1-(469)-742-2500, 800-535-4492
FDA Registration: 2183449 Year Established: 1980 Employee Count: ~200 Quality: ISO Certified
Products: Probes (FDA Code: HXB), Femoral IM Nails, Ankle External Fixators, Elbow External Fixators, Hand External Fixators, Static External Fixators, ...
Orthofix Inc. designs, manufactures & distributes medical equipment, mainly for the orthopedic market. Our orthopedics, spine and sports medicine divisions offer innovative treatment options for adult more...
Cadence, Inc. | Address: 9 Technology Drive,, Staunton, Virginia 24401, USA
https://www.cadenceinc.com | Send Inquiry | Phone: +1-(540)-248-2200, 800-252 3371
Products: Dissectors, Aortic Punches, Trocars, Biopsy Punches (FDA Code: FCI), Surgical Blades, Lancet Devices, ...
Cadence, Inc is a manufacturer of surgical instruments. We offer the sharpest incisional components and assemblies for endoscopic, cardiovascular, ophthalmic, orthopedic & diagnostic procedures. Our p more...
https://www.cadenceinc.com | Send Inquiry | Phone: +1-(540)-248-2200, 800-252 3371
Products: Dissectors, Aortic Punches, Trocars, Biopsy Punches (FDA Code: FCI), Surgical Blades, Lancet Devices, ...
Cadence, Inc is a manufacturer of surgical instruments. We offer the sharpest incisional components and assemblies for endoscopic, cardiovascular, ophthalmic, orthopedic & diagnostic procedures. Our p more...
Ad-Tech Medical Instrument Corporation | Address: 1901 William Street, Racine, Wisconsin 53404, USA
www.adtechmedical.com | Send Inquiry | Phone: +1-(262)-634-1555
FDA Registration: 2183456 Year Established: 1983 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Electrocorticography, Intracranial Electrodes, Special Application Electrodes, Subpial Transectors, Brain Biopsy Needles, Brain Biopsy Needle Guides, ...
Ad-Tech Medical Instrument Corporation provides the finest devices for the surgical treatment of epilepsy, as well as devices for neurosurgery. We are an ISO 13485: 2003 certified company. We offer pr more...
www.adtechmedical.com | Send Inquiry | Phone: +1-(262)-634-1555
FDA Registration: 2183456 Year Established: 1983 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Electrocorticography, Intracranial Electrodes, Special Application Electrodes, Subpial Transectors, Brain Biopsy Needles, Brain Biopsy Needle Guides, ...
Ad-Tech Medical Instrument Corporation provides the finest devices for the surgical treatment of epilepsy, as well as devices for neurosurgery. We are an ISO 13485: 2003 certified company. We offer pr more...
Osseon Therapeutics, Inc. | Address: 2330 Circadian Way, Santa Rosa, California 95407, USA
www.osseon.com | Send Inquiry | Phone: +1-(707)-636 5940
Products: Drill Bit (FDA Code: HTW), Tamps (FDA Code: HXG), Instruments for Minimally Invasive Surgery, Osteoporosis Care, Disposable Aspiration and Injection Needle (FDA Code: GAA), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), ...
Osseon™ Therapeutics, Inc. specializes in bone cement delivery devices as well as complementary bone cement composite for treating symptomatic compression fractures of the vertebral spine which more...
www.osseon.com | Send Inquiry | Phone: +1-(707)-636 5940
Products: Drill Bit (FDA Code: HTW), Tamps (FDA Code: HXG), Instruments for Minimally Invasive Surgery, Osteoporosis Care, Disposable Aspiration and Injection Needle (FDA Code: GAA), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), ...
Osseon™ Therapeutics, Inc. specializes in bone cement delivery devices as well as complementary bone cement composite for treating symptomatic compression fractures of the vertebral spine which more...
K. W. Griffen Co. | Address: 100 Pearl St., Norwalk, Connecticut 06850, USA
Send Inquiry | Phone: +1-(203)-846-1923
FDA Registration: 1211177 Year Established: 1962 Annual Revenues: USD 1-5 Million Employee Count: ~60 Quality: ISO 9000, CE Certified
Products: Spreaders, Surgical Marking Pens (FDA Code: HRP), Elastic Bandages (FDA Code: FQM), First Aid Kits, Irrigation Cannulas, Operating Room Scrub Brush (FDA Code: GEC), ...
K. W. Griffen Co. is a manufacturer of medical & surgical instruments. We offer first aid & hospital kits, surgical distractors, spreaders, separators, manipulators, implant positioners, suction & irr more...
Send Inquiry | Phone: +1-(203)-846-1923
FDA Registration: 1211177 Year Established: 1962 Annual Revenues: USD 1-5 Million Employee Count: ~60 Quality: ISO 9000, CE Certified
Products: Spreaders, Surgical Marking Pens (FDA Code: HRP), Elastic Bandages (FDA Code: FQM), First Aid Kits, Irrigation Cannulas, Operating Room Scrub Brush (FDA Code: GEC), ...
K. W. Griffen Co. is a manufacturer of medical & surgical instruments. We offer first aid & hospital kits, surgical distractors, spreaders, separators, manipulators, implant positioners, suction & irr more...
Biomet Microfixation | Address: 1520 Tradeport Dr., Jacksonville, Florida 32218-2480, USA
www.biometmicrofixation.com | Send Inquiry | Phone: +1-(904)-741-4400, 800-874-7711
FDA Registration: 1032347 Year Established: 1965
Products: Forceps (FDA Code: HTD), Demineralized Bone Matrix, Lacrimal Probes (FDA Code: HNL), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Orbital Retractors, ...
Biomet Microfixation manufactures a complete range of craniomaxillofacial products. We offer products for neurosurgical, plastic, oral & maxillofacial, craniofacial, pediatric, ENT and cardiothoracic more...
www.biometmicrofixation.com | Send Inquiry | Phone: +1-(904)-741-4400, 800-874-7711
FDA Registration: 1032347 Year Established: 1965
Products: Forceps (FDA Code: HTD), Demineralized Bone Matrix, Lacrimal Probes (FDA Code: HNL), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Orbital Retractors, ...
Biomet Microfixation manufactures a complete range of craniomaxillofacial products. We offer products for neurosurgical, plastic, oral & maxillofacial, craniofacial, pediatric, ENT and cardiothoracic more...
Tegra Medical | Address: 8 Ledgewood Blvd, Dartmouth, Massachusetts 2747, USA
tegramedical.com | Phone: +1-(508)-541-4221
FDA Registration: 1226191 Year Established: 2007 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9002 Certified
Products: Guidewires, Minimally Invasive Breast Biopsy, Arthroscopy Shaver Systems, Spinal Needles, Huber Needles, Knot Pusher, ...
Tegra Medical provides manufacturing solutions for complex wire and tubular products for the medical device & life sciences industry. We specialize in orthopaedics, minimally invasive surgeries, inter more...
tegramedical.com | Phone: +1-(508)-541-4221
FDA Registration: 1226191 Year Established: 2007 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9002 Certified
Products: Guidewires, Minimally Invasive Breast Biopsy, Arthroscopy Shaver Systems, Spinal Needles, Huber Needles, Knot Pusher, ...
Tegra Medical provides manufacturing solutions for complex wire and tubular products for the medical device & life sciences industry. We specialize in orthopaedics, minimally invasive surgeries, inter more...
Sponsored Links
FDA Code / Regulation: GAH / 878.4800
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.
