Surgical Cutter Suppliers
Limit companies to: Worldwide USA
Autosuture | Address: 150 Glover Avenue, Norwalk, Connecticut 06856, USA 
www.autosuture.com | Send Inquiry | Phone: +1-(800)-722-8772
Annual Revenues: > USD 1 Billion Employee Count: ~5780 Quality: ISO 9001, ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Retractors, Scissors, Meniscal Repair Systems, Absorbable Suture Anchors, Suture Anchors, ...
Autosuture offers a complete line of surgical products and instrumentation that surgeons utilize for laparoscopic, endoscopic & traditional open surgical procedures & lymphatic mapping. We are an ISO more...
www.autosuture.com | Send Inquiry | Phone: +1-(800)-722-8772
Annual Revenues: > USD 1 Billion Employee Count: ~5780 Quality: ISO 9001, ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Retractors, Scissors, Meniscal Repair Systems, Absorbable Suture Anchors, Suture Anchors, ...
Autosuture offers a complete line of surgical products and instrumentation that surgeons utilize for laparoscopic, endoscopic & traditional open surgical procedures & lymphatic mapping. We are an ISO more...
KLS Martin, L.P. | Address: 11239-1 St.Johns Industrial Parkway S, Jacksonville, Florida 32246-7652, USA
www.klsmartinusa.com | Send Inquiry | Phone: +1-(904)-641-7746, 800-625-1557
FDA Registration: 1057946 Year Established: 1993 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9001 Certified
Products: Elevators, Instruments, Castroviejo Calipers, Neurological Instruments, Pituitary Scoops, Cervical Spine Retractor System, Hand Held Instruments, Periosteals Elevators, ...
KLS Martin, L.P. focuses on surgical fields. Our mario® instrument management software manages & controls sterile supplies according to economic, technical & process-oriented criteria. Our C-plate more...
www.klsmartinusa.com | Send Inquiry | Phone: +1-(904)-641-7746, 800-625-1557
FDA Registration: 1057946 Year Established: 1993 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9001 Certified
Products: Elevators, Instruments, Castroviejo Calipers, Neurological Instruments, Pituitary Scoops, Cervical Spine Retractor System, Hand Held Instruments, Periosteals Elevators, ...
KLS Martin, L.P. focuses on surgical fields. Our mario® instrument management software manages & controls sterile supplies according to economic, technical & process-oriented criteria. Our C-plate more...
Marina Medical Instruments Inc. | Address: 955 Shotgun Rd, Sunrise, Florida 33326, USA
www.marinamedical.com | Send Inquiry | Phone: +1-(954)-924-4418, 800-697-1119
FDA Registration: 2084346 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Curettes, Hemostatic Mosquito Forceps, Adson Tissue Forceps, Jewelers Bipolar Forceps, Jaeger Lid Plates, Bone Curettes, ...
Marina Medical Instruments Inc. supplies medical instruments. Our product range comprises of vaginal agenesis, fan retractors, pelvic surgery, surgical caps, scopes, electrosurgical, cystoscopy & bari more...
www.marinamedical.com | Send Inquiry | Phone: +1-(954)-924-4418, 800-697-1119
FDA Registration: 2084346 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Curettes, Hemostatic Mosquito Forceps, Adson Tissue Forceps, Jewelers Bipolar Forceps, Jaeger Lid Plates, Bone Curettes, ...
Marina Medical Instruments Inc. supplies medical instruments. Our product range comprises of vaginal agenesis, fan retractors, pelvic surgery, surgical caps, scopes, electrosurgical, cystoscopy & bari more...
Hospira, Inc. | Address: 275 N. Field Dr., Lake Forest, Illinois 60045, USA
www.hospira.com | Send Inquiry | Phone: +1-(224)-212-2000
FDA Registration: 1925262 Year Established: 1930 Annual Revenues: > USD 1 Billion Employee Count: ~16000 Quality: ISO 9002 Certified
Products: Anesthesia Equipment, Irrigating Solutions, Pulmonary Artery Catheters, Anesthetics, Antibiotics, Aspirators, ...
Hospira, Inc. focuses on medication delivery systems & critical care devices, which include the next-generation patient-controlled analgesia device, lifeCare PCA®, the plum A+® multichannel in more...
www.hospira.com | Send Inquiry | Phone: +1-(224)-212-2000
FDA Registration: 1925262 Year Established: 1930 Annual Revenues: > USD 1 Billion Employee Count: ~16000 Quality: ISO 9002 Certified
Products: Anesthesia Equipment, Irrigating Solutions, Pulmonary Artery Catheters, Anesthetics, Antibiotics, Aspirators, ...
Hospira, Inc. focuses on medication delivery systems & critical care devices, which include the next-generation patient-controlled analgesia device, lifeCare PCA®, the plum A+® multichannel in 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: Speech & Testing Equipment, Impedance Testing Systems, Audiometers & Accessories, Evoked Response Testing Systems, Infant Screening & Testing Units, Otoacoustic Emission Test Equipment, ...
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: Speech & Testing Equipment, Impedance Testing Systems, Audiometers & Accessories, Evoked Response Testing Systems, Infant Screening & Testing Units, Otoacoustic Emission Test Equipment, ...
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...
DePuy Orthopaedics, Inc | Address: 700 Orthopaedic Drive, Warsaw, Indiana 46582, USA
www.depuy.com | Send Inquiry | Phone: +1-(574)-267-8143, 800-473-3789
Year Established: 1895 Employee Count: ~600
Products: Bone Cement (FDA Code: LOD), Orthopedics, Compression Hip Screw, Free Lock Compression Hip Screws, FRS-Fusion and Reconstruction System, Acetabular Cup System, Mobile-Bearing Knee System, ...
DePuy, Inc., provides healthcare solutions in orthopaedics, spinal care, pain management, and central nervous system. Our orthopaedic devices and supplies include hip, knee, extremity, trauma, cement more...
www.depuy.com | Send Inquiry | Phone: +1-(574)-267-8143, 800-473-3789
Year Established: 1895 Employee Count: ~600
Products: Bone Cement (FDA Code: LOD), Orthopedics, Compression Hip Screw, Free Lock Compression Hip Screws, FRS-Fusion and Reconstruction System, Acetabular Cup System, Mobile-Bearing Knee System, ...
DePuy, Inc., provides healthcare solutions in orthopaedics, spinal care, pain management, and central nervous system. Our orthopaedic devices and supplies include hip, knee, extremity, trauma, cement more...
Zimmer, Inc. | Address: P.O. Box 708 ,1800 West Center Street, Warsaw, Indiana 46581-0708, USA
www.zimmer.com | Phone: +1-(574)-372-4790, 800-613-6131
FDA Registration: 1822565 Year Established: 1927 Annual Revenues: > USD 1 Billion Employee Count: ~7600 Quality: ISO 9001, CE Certified
Products: Splints, Synthetic Spacers, Patellar Implants, Femoral Components, Total Shoulder Systems, Aspirators, ...
Zimmer, Inc. manufactures orthopedic products and instruments. We specialize in joint replacement solutions for knee pain & hip pain. We deliver comprehensive spine care solutions for acute and chroni more...
www.zimmer.com | Phone: +1-(574)-372-4790, 800-613-6131
FDA Registration: 1822565 Year Established: 1927 Annual Revenues: > USD 1 Billion Employee Count: ~7600 Quality: ISO 9001, CE Certified
Products: Splints, Synthetic Spacers, Patellar Implants, Femoral Components, Total Shoulder Systems, Aspirators, ...
Zimmer, Inc. manufactures orthopedic products and instruments. We specialize in joint replacement solutions for knee pain & hip pain. We deliver comprehensive spine care solutions for acute and chroni 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: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
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: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
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: Arthroscopes (FDA Code: HRX), Bio Absorbable Plating Systems, Bone Mallets (FDA Code: HXL), Anterior Old Plating Systems, Awl (FDA Code: HWJ), Bender (FDA Code: HXW), ...
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: Arthroscopes (FDA Code: HRX), Bio Absorbable Plating Systems, Bone Mallets (FDA Code: HXL), Anterior Old Plating Systems, Awl (FDA Code: HWJ), Bender (FDA Code: HXW), ...
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...
Thompson Surgical Instruments, Inc. | Address: 10170 E Cherry Bend Rd, Traverse City, Massachusetts 49684, USA
www.thompsonsurgical.com | Send Inquiry | Phone: +1-(231)-922-0177,800-227-7543
FDA Registration: 1450428 Year Established: 1983 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9000, CE Certified
Products: Anterior, Anterior Cruciate Ligament Surgical Reconstruction System, Anterior Odontoid Screw Fixation, Anterior Old Plating Systems, Flexible Scope Holder, Laparoscopic Retractor, ...
Thompson Surgical Instruments, Inc. produces a mechanical retractor which offers one frame for all exposure needs, multi-planed retraction and unlimited customization. Our anterior cervical access kit more...
www.thompsonsurgical.com | Send Inquiry | Phone: +1-(231)-922-0177,800-227-7543
FDA Registration: 1450428 Year Established: 1983 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9000, CE Certified
Products: Anterior, Anterior Cruciate Ligament Surgical Reconstruction System, Anterior Odontoid Screw Fixation, Anterior Old Plating Systems, Flexible Scope Holder, Laparoscopic Retractor, ...
Thompson Surgical Instruments, Inc. produces a mechanical retractor which offers one frame for all exposure needs, multi-planed retraction and unlimited customization. Our anterior cervical access kit more...
Stryker | Address: 2825 Airview Boulevard, Kalamazoo, Michigan 49002, USA
www.stryker.com/en-us/index.htm | Phone: +1-(269)-385-2600
Products: Saws (FDA Code: HSO), Titanium Plating Systems, Resorbable Plating Systems, Fracture Hardware, Cannulated Screws, Pelvic Plating Systems, ...
Stryker offers a full range of laparoscopic products that meet the performance needed by surgeons. From the uniform image created by our laparoscopes to our StrykeFlow II suction irrigation system, we more...
www.stryker.com/en-us/index.htm | Phone: +1-(269)-385-2600
Products: Saws (FDA Code: HSO), Titanium Plating Systems, Resorbable Plating Systems, Fracture Hardware, Cannulated Screws, Pelvic Plating Systems, ...
Stryker offers a full range of laparoscopic products that meet the performance needed by surgeons. From the uniform image created by our laparoscopes to our StrykeFlow II suction irrigation system, we more...
Scanlan International | Address: One Scanlan Plaza, St. Paul, Minnesota 55107, USA
www.scanlaninternational.com | Send Inquiry | Phone: +1-(651)-298-0997, 800-328-9458
FDA Registration: 2126670 Year Established: 1921 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Clamps, Scissors, Vascular Clamps (FDA Code: DXC), Micro Surgery Instruments, Scissors, Surgical Scissors, Cartilage Scissors, ...
Scanlan International designs and manufactures surgical instrumentation. Our product categories are cardiac/vascular, neurosurgical, single-use products, instrument care and custom design. Our Scanlan more...
www.scanlaninternational.com | Send Inquiry | Phone: +1-(651)-298-0997, 800-328-9458
FDA Registration: 2126670 Year Established: 1921 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Clamps, Scissors, Vascular Clamps (FDA Code: DXC), Micro Surgery Instruments, Scissors, Surgical Scissors, Cartilage Scissors, ...
Scanlan International designs and manufactures surgical instrumentation. Our product categories are cardiac/vascular, neurosurgical, single-use products, instrument care and custom design. Our Scanlan 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: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
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: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
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...
Ethicon Endo-Surgery, Inc. | Address: 4545 Creek Road, Cincinnati, Ohio 45242-2839, USA
www.ethiconendo.com | Send Inquiry | Phone: +1-(513)-337-8901, (800)-873-3636
FDA Registration: 3005075853 Annual Revenues: USD 1-5 Million Employee Count: ~3000 Quality: CE Certified
Products: Clamps, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Procedure Trays, Retractors, Powered Surgical Laser Instrument (FDA Code: GEX), ...
Ethicon Endo-Surgery, Inc. produces & markets advanced medical devices for minimally invasive and open surgical procedures. We offer products like brest care products, surgical stapling products, ener more...
www.ethiconendo.com | Send Inquiry | Phone: +1-(513)-337-8901, (800)-873-3636
FDA Registration: 3005075853 Annual Revenues: USD 1-5 Million Employee Count: ~3000 Quality: CE Certified
Products: Clamps, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Procedure Trays, Retractors, Powered Surgical Laser Instrument (FDA Code: GEX), ...
Ethicon Endo-Surgery, Inc. produces & markets advanced medical devices for minimally invasive and open surgical procedures. We offer products like brest care products, surgical stapling products, ener 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: Curettes, Drills, Titanium Plating Systems, Suction Tubes, Dural Substitute, Posterior, ...
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: Curettes, Drills, Titanium Plating Systems, Suction Tubes, Dural Substitute, Posterior, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
Sklar Instruments | Address: 889 S. Matlack St, West Chester, Pennsylvania 19382, USA
www.sklarcorp.com | Send Inquiry | Phone: +1-(610)-430-3200, 800-221-2166
FDA Registration: 2431166
Products: Alligator Forceps, Adult Stethoscope, Aneroid Sphygmomanometer, Aortic Aneurysm Clamps, Anastomosis Clamps, Adult Laryngoscope Lamp, ...
Sklar Instruments supplies surgical instruments. Our product categories are arthroscopy, dental, dermal, diagnostic, electrosurgery, genitourinary, and orthodontics. Our Sklar Tite™ line of seal more...
www.sklarcorp.com | Send Inquiry | Phone: +1-(610)-430-3200, 800-221-2166
FDA Registration: 2431166
Products: Alligator Forceps, Adult Stethoscope, Aneroid Sphygmomanometer, Aortic Aneurysm Clamps, Anastomosis Clamps, Adult Laryngoscope Lamp, ...
Sklar Instruments supplies surgical instruments. Our product categories are arthroscopy, dental, dermal, diagnostic, electrosurgery, genitourinary, and orthodontics. Our Sklar Tite™ line of seal 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: Proximal Femoral & Recon Nails, Spinal Orthoses, Bone Screws, Compression Distraction, Clicker, Counter Nuts, Threaded Bars, ...
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: Proximal Femoral & Recon Nails, Spinal Orthoses, Bone Screws, Compression Distraction, Clicker, Counter Nuts, Threaded Bars, ...
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...
Zimmer Dental, Inc. | Address: 1900 Aston Ave., Carlsbad, California 92008, USA
www.zimmerdental.com | Phone: +1-(760)-929-4300, 800-854-7019
FDA Registration: 2023141 Year Established: 1927 Annual Revenues: USD 100-500 Million Employee Count: ~410 Quality: ISO 13485, CE Certified
Products: Synthetic Bone Graft Substitute Granules, Bone Graft Substitute Plugs, Bone Graft Substitute Blocks, Bone Graft Substitute Osteotomy Wedges, Bone Graft Harvester, Allograft Bone Graft, ...
Zimmer Dental, Inc. specializes in dental implant products. Our product portfolio comprises of root-form endosseous dental implants, prosthetic attachments for restoration, surgical instrumentation, c more...
www.zimmerdental.com | Phone: +1-(760)-929-4300, 800-854-7019
FDA Registration: 2023141 Year Established: 1927 Annual Revenues: USD 100-500 Million Employee Count: ~410 Quality: ISO 13485, CE Certified
Products: Synthetic Bone Graft Substitute Granules, Bone Graft Substitute Plugs, Bone Graft Substitute Blocks, Bone Graft Substitute Osteotomy Wedges, Bone Graft Harvester, Allograft Bone Graft, ...
Zimmer Dental, Inc. specializes in dental implant products. Our product portfolio comprises of root-form endosseous dental implants, prosthetic attachments for restoration, surgical instrumentation, c more...
Sentreheart Inc. | Address: 300 Saginaw Drive, Redwood, California 94063, USA
www.sentreheart.com | Send Inquiry | Phone: +1-(650)-3541200
FDA Registration: 3005802238 Year Established: 2005
Products: Balloon Catheters, Occlusion Balloon System, Guidewire Catheter (FDA Code: DQX), General Surgical Manual Instrument (FDA Code: MDM), Ligature Passing and Knot Tying Instrument (FDA Code: HCF), Guide Wire Systems, ...
Sentreheart Inc. develops & manufactures suture delivery devices. We also offer occlusion balloons and guide wire systems. Our Lariat™ suture delivery device is a remote suture delivery system f more...
www.sentreheart.com | Send Inquiry | Phone: +1-(650)-3541200
FDA Registration: 3005802238 Year Established: 2005
Products: Balloon Catheters, Occlusion Balloon System, Guidewire Catheter (FDA Code: DQX), General Surgical Manual Instrument (FDA Code: MDM), Ligature Passing and Knot Tying Instrument (FDA Code: HCF), Guide Wire Systems, ...
Sentreheart Inc. develops & manufactures suture delivery devices. We also offer occlusion balloons and guide wire systems. Our Lariat™ suture delivery device is a remote suture delivery system f more...
Pivot Medical, Inc. | Address: 762 Palomar Avenue, Sunnyvale, California 94085, USA
Phone: +1-(408)-7741452
Products: General & Plastic Surgery Surgical Cannula (FDA Code: GEA), Surgical Cutter (FDA Code: FZT), ...
Pivot Medical, Inc. deals with surgical cannulas and surgical cutters. more...
Phone: +1-(408)-7741452
Products: General & Plastic Surgery Surgical Cannula (FDA Code: GEA), Surgical Cutter (FDA Code: FZT), ...
Pivot Medical, Inc. deals with surgical cannulas and surgical cutters. more...
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FDA Code / Regulation: FZT / 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.
