Surgical Retractor Systems Suppliers
Limit companies to: Worldwide USA
Applied Medical | Address: 22872 Avenida Empresa, Rancho Santa Margarita, California 92688, USA 
www.appliedmedical.com | Send Inquiry | Phone: +1-(949)-713-8000
FDA Registration: 2027111 Year Established: 1987 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO, CE Certified
Products: Catheter Introducers (FDA Code: DYB), Graspers, Surgical Drapes & Packs (FDA Code: KKX), Thrombectomy Catheter, Embolectomy Catheters (FDA Code: DXE), Arterial Embolectomy Catheter, ...
Applied Medical is associated with clinical areas such as general surgery, urology, vascular, cardiac, colorectal and Ob/Gyn surgery. We have introduced GelPort® laparoscopic system, Kii® abdo more...
www.appliedmedical.com | Send Inquiry | Phone: +1-(949)-713-8000
FDA Registration: 2027111 Year Established: 1987 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO, CE Certified
Products: Catheter Introducers (FDA Code: DYB), Graspers, Surgical Drapes & Packs (FDA Code: KKX), Thrombectomy Catheter, Embolectomy Catheters (FDA Code: DXE), Arterial Embolectomy Catheter, ...
Applied Medical is associated with clinical areas such as general surgery, urology, vascular, cardiac, colorectal and Ob/Gyn surgery. We have introduced GelPort® laparoscopic system, Kii® abdo more...
Mach Labs, L.P. | Address: 2682 F Middlefield Road, Redwood City, California 94063, USA
Products: Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), Blood Collection Lancet (FDA Code: FMK), General Medical Device, Custom Designed Medical Devices, ...
Mach Labs, L.P. provides medical devices. We specialize in circulatory medicine, surgical tools, aesthetics and bariatrics. more...
Products: Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), Blood Collection Lancet (FDA Code: FMK), General Medical Device, Custom Designed Medical Devices, ...
Mach Labs, L.P. provides medical devices. We specialize in circulatory medicine, surgical tools, aesthetics and bariatrics. more...
Invuity, Inc. | Address: 39 Stillman Street, San Francisco, California 94107, USA
www.invuity.com | Send Inquiry | Phone: +1-(866)-711 7768
FDA Registration: 3011394215
Products: Probes (FDA Code: HXB), Surgical Retractor Systems (FDA Code: GAD), Rib Rongeurs (FDA Code: HTX), Medical Probes (FDA Code: HXB), Surgical Retractor (FDA Code: GAD), Surgical Instrument Tray (FDA Code: FSM), ...
Invuity, Inc. specializes in the development and marketing of numerous complex medical technologies. The BriteField™ port system provides optimized illumination and visualization during minimall more...
www.invuity.com | Send Inquiry | Phone: +1-(866)-711 7768
FDA Registration: 3011394215
Products: Probes (FDA Code: HXB), Surgical Retractor Systems (FDA Code: GAD), Rib Rongeurs (FDA Code: HTX), Medical Probes (FDA Code: HXB), Surgical Retractor (FDA Code: GAD), Surgical Instrument Tray (FDA Code: FSM), ...
Invuity, Inc. specializes in the development and marketing of numerous complex medical technologies. The BriteField™ port system provides optimized illumination and visualization during minimall more...
Spinevision, Inc. | Address: 301 Howard St., Suite 970, San Francisco, California 94105, USA
www.spinevision.net | Phone: +1-(415)-5128001
FDA Registration: 1067145
Products: Probes (FDA Code: HXB), Surgical Retractor Systems (FDA Code: GAD), Cervical Spine Retractor System, Hand Held Instruments, Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), Small Depth Gauge (FDA Code: HTJ), ...
Spinevision, Inc.provides spinal treatment products. We offer PLUS®, X-PLUS™, UNI-Thread®, Spacevision® and C3® products. UNI-Thread® versatile thoraco-lumbar spinal system h more...
www.spinevision.net | Phone: +1-(415)-5128001
FDA Registration: 1067145
Products: Probes (FDA Code: HXB), Surgical Retractor Systems (FDA Code: GAD), Cervical Spine Retractor System, Hand Held Instruments, Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), Small Depth Gauge (FDA Code: HTJ), ...
Spinevision, Inc.provides spinal treatment products. We offer PLUS®, X-PLUS™, UNI-Thread®, Spacevision® and C3® products. UNI-Thread® versatile thoraco-lumbar spinal system h more...
Axiom Medical Inc | Address: 19320 Van Ness Avenue, Torrance, California 90501, USA
www.axiommed.com | Send Inquiry | Phone: +1-(310)-533-9020
FDA Registration: 2020735 Year Established: 1976 Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: Anesthesia Equipment, Sutures, Silicone Tubing, Disposables, Catheters, Volumetric Infusion Pumps, ...
Axiom Medical Inc offers a line of medical devices and medical products. We produce quality silicone and PVC disposable wound drainage catheters for all types of surgery. Our flattened contour mediast more...
www.axiommed.com | Send Inquiry | Phone: +1-(310)-533-9020
FDA Registration: 2020735 Year Established: 1976 Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: Anesthesia Equipment, Sutures, Silicone Tubing, Disposables, Catheters, Volumetric Infusion Pumps, ...
Axiom Medical Inc offers a line of medical devices and medical products. We produce quality silicone and PVC disposable wound drainage catheters for all types of surgery. Our flattened contour mediast more...
Seaspine | Address: 2302 La Mirada Drive, Vista, California 92081-7862, USA
www.seaspine.com | Send Inquiry | Phone: +1-(760)-727-8399
Year Established: 2002 Annual Revenues: USD 10-25 Million Employee Count: ~20
Products: Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Drill Bit (FDA Code: HTW), ...
Seaspine provides medical products for the spine fusion market. Our Cardiff™ anterior cervical plate system has a low profile design. This system has large windows for viewing the disc space and more...
www.seaspine.com | Send Inquiry | Phone: +1-(760)-727-8399
Year Established: 2002 Annual Revenues: USD 10-25 Million Employee Count: ~20
Products: Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Drill Bit (FDA Code: HTW), ...
Seaspine provides medical products for the spine fusion market. Our Cardiff™ anterior cervical plate system has a low profile design. This system has large windows for viewing the disc space and more...
Spine Wave, Inc. | Address: Three Enterprise Drive, Suite 210, Shelton, Connecticut 06484, USA
www.spinewave.com | Send Inquiry | Phone: +1-(203)-944-9494, 877-844-4225
FDA Registration: 3004638600
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), ...
Spine Wave, Inc. deals with the development and delivery of innovative medical devices for the treatment of spinal disorders. Our trade mark products are Spine Wave™, StaXx®, CapSure®, a more...
www.spinewave.com | Send Inquiry | Phone: +1-(203)-944-9494, 877-844-4225
FDA Registration: 3004638600
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), ...
Spine Wave, Inc. deals with the development and delivery of innovative medical devices for the treatment of spinal disorders. Our trade mark products are Spine Wave™, StaXx®, CapSure®, a 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...
American Medicals | Address: 10720 Crosswicks Rd. South, Jacksonville, Florida 32256, USA
www.americanmedicals.com | Send Inquiry | Phone: +1-(904)-6469451
FDA Registration: 3004552850
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Retractor Systems (FDA Code: GAD), Scalpel Handle (FDA Code: GDZ), Nasal Scissors Straight (FDA Code: KBD), Bone Clamp (FDA Code: HXD), ...
American Medicals is a distributor and marketer of medical, surgical and healthcare products. Our products include bedside utensils, grooming aids, disposable apparel, isolation gowns, dental chairs, more...
www.americanmedicals.com | Send Inquiry | Phone: +1-(904)-6469451
FDA Registration: 3004552850
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Retractor Systems (FDA Code: GAD), Scalpel Handle (FDA Code: GDZ), Nasal Scissors Straight (FDA Code: KBD), Bone Clamp (FDA Code: HXD), ...
American Medicals is a distributor and marketer of medical, surgical and healthcare products. Our products include bedside utensils, grooming aids, disposable apparel, isolation gowns, dental chairs, more...
Toby Orthopaedics | Address: 3773 Matheson Ave, Miami, Florida 33133, USA
www.tobyortho.com | Send Inquiry | Phone: +1-(305)-665-8699
FDA Registration: 3008747271
Products: Tendon Implants, Surgical Retractor Systems (FDA Code: GAD), Tendon Instruments, Orthopedic Instruments, Bone Screws, Surgical Retractor (FDA Code: GAD), ...
Toby Orthopaedics specializes in the production of orthopedics and related products. Our products include flexor tendon repair tools, flexor tendon repair implantables and long bone plates. Our flexor more...
www.tobyortho.com | Send Inquiry | Phone: +1-(305)-665-8699
FDA Registration: 3008747271
Products: Tendon Implants, Surgical Retractor Systems (FDA Code: GAD), Tendon Instruments, Orthopedic Instruments, Bone Screws, Surgical Retractor (FDA Code: GAD), ...
Toby Orthopaedics specializes in the production of orthopedics and related products. Our products include flexor tendon repair tools, flexor tendon repair implantables and long bone plates. Our flexor more...
Rotburg Instruments Of America Inc. | Address: 1560 Sawgrass Corporate Pkwy., 4th Floor, Sunrise, Florida 33323, USA
www.rotburg.com | Send Inquiry | Phone: +1-(954)-331-8046
Products: Fetal Monitors, Biopsy Forceps, Surgical Retractor Systems (FDA Code: GAD), Repair Services, Cameras Repair Services, Electrosurgical Pens, ...
Rotburg Instruments Of America Inc. are providers of medical equipments. We offer products for minimally invasive surgeries, disposable elctrodes, electrosurgical pencils, reusable biopsy forceps, fet more...
www.rotburg.com | Send Inquiry | Phone: +1-(954)-331-8046
Products: Fetal Monitors, Biopsy Forceps, Surgical Retractor Systems (FDA Code: GAD), Repair Services, Cameras Repair Services, Electrosurgical Pens, ...
Rotburg Instruments Of America Inc. are providers of medical equipments. We offer products for minimally invasive surgeries, disposable elctrodes, electrosurgical pencils, reusable biopsy forceps, fet more...
Raja Trading Company, Inc. | Address: 801 South Olive Ave., Ste. 124, West Palm Bch, Florida 33401, USA
Phone: +1-(561)-868-4600
Products: Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), AC-Powered Surgical Instrument Motor (FDA Code: GEY), Dermabrasion Brush (FDA Code: GFE), General & Plastic Surgery Surgical Burr (FDA Code: GFF), ...
Raja Trading Company, Inc. manufactures surgical products. We supply medical products that include AC powered surgical instrument motors, dermabrasion brushes, general & plastic surgery surgical burrs more...
Phone: +1-(561)-868-4600
Products: Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), AC-Powered Surgical Instrument Motor (FDA Code: GEY), Dermabrasion Brush (FDA Code: GFE), General & Plastic Surgery Surgical Burr (FDA Code: GFF), ...
Raja Trading Company, Inc. manufactures surgical products. We supply medical products that include AC powered surgical instrument motors, dermabrasion brushes, general & plastic surgery surgical burrs more...
Precision Products, Inc. | Address: 681 North Varnell Rd., Tunnel Hill, Georgia 30755, USA
Phone: +1-(706)-673-6900 800-220-9221
Products: Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), ...
Precision Products, Inc. manufactures surgical retractors. more...
Phone: +1-(706)-673-6900 800-220-9221
Products: Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), ...
Precision Products, Inc. manufactures surgical retractors. more...
R Medical Inc. | Address: 28835 N. Herky Drive, Unit 101, Lake Bluff, Illinois 60044, USA
r-medicalinc.com | Send Inquiry | Phone: +1-(847)-816 1615
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
R Medical Inc. provides instruments & equipment for both open surgery & for endoscopy. We specialize in Easy-port® trocars, the Rudolf laparoscopy system instruments with cameras and light sources more...
r-medicalinc.com | Send Inquiry | Phone: +1-(847)-816 1615
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
R Medical Inc. provides instruments & equipment for both open surgery & for endoscopy. We specialize in Easy-port® trocars, the Rudolf laparoscopy system instruments with cameras and light sources more...
Bio-Bridge Science, Inc. | Address: 1211 West 22nd St., Suite 615, Oak Brook, Illinois 60523, USA
www.bbsinstruments.com | Send Inquiry | Phone: +1-(630)-9280869
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Bone Hooks (FDA Code: KIK), ...
Bio-Bridge Science, Inc. is a provider of surgical and dental instruments. Our surgical instruments include surgical clamps, forceps, scalpel handles, scissors, tweezers and retractors. Our dental ins more...
www.bbsinstruments.com | Send Inquiry | Phone: +1-(630)-9280869
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Bone Hooks (FDA Code: KIK), ...
Bio-Bridge Science, Inc. is a provider of surgical and dental instruments. Our surgical instruments include surgical clamps, forceps, scalpel handles, scissors, tweezers and retractors. Our dental ins more...
Instrumed International, Inc. | Address: 626 Cooper Court, Schaumburg, Illinois 60173, USA
www.instrumedinc.biz | Phone: +1-(847)-908-0292
FDA Registration: 1421101
Products: Laparoscopic Equipment, Vaginal Retractors (FDA Code: HDL), Micro Surgery Instruments, Bipolar Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Retractor System, ...
Instrumed International, Inc. specializes in providing reusable surgical instruments. We offer surgical products for bipolar, CV/thoracic, ENT, general, hand & micro surgery, laparoscopic, laryngeal, more...
www.instrumedinc.biz | Phone: +1-(847)-908-0292
FDA Registration: 1421101
Products: Laparoscopic Equipment, Vaginal Retractors (FDA Code: HDL), Micro Surgery Instruments, Bipolar Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Retractor System, ...
Instrumed International, Inc. specializes in providing reusable surgical instruments. We offer surgical products for bipolar, CV/thoracic, ENT, general, hand & micro surgery, laparoscopic, laryngeal, more...
Rica Surgical Products, Inc. | Address: 9207 Ivanhoe St., Schiller Park, Illinois 60176, USA
www.ricasurgical.com | Send Inquiry | Phone: +1-(847)-6715600
FDA Registration: 1419732
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Hooks, Microsurgical Knives, Orthopedics Accessory Instruments, Skin Staplers, ...
Rica Surgical Products, Inc. manufactures surgical instruments. Our products include dressing and tissue forceps, ENT instruments, hemostatic forceps and hooks. We provide needle holders, OB/GYN instr more...
www.ricasurgical.com | Send Inquiry | Phone: +1-(847)-6715600
FDA Registration: 1419732
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Hooks, Microsurgical Knives, Orthopedics Accessory Instruments, Skin Staplers, ...
Rica Surgical Products, Inc. manufactures surgical instruments. Our products include dressing and tissue forceps, ENT instruments, hemostatic forceps and hooks. We provide needle holders, OB/GYN instr more...
Uresil, LLC | Address: 5418 W. Touhy Avenue, Skokie, Illinois 60077-3232, USA
www.uresil.com | Send Inquiry | Phone: +1-(847)-982-0200, 800-538-7374
FDA Registration: 1450395 Year Established: 1986 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO 9002 Certified
Products: Drainage Catheter, Adhesive Bandages (FDA Code: KGX), Surgical Retractor Systems (FDA Code: GAD), Introducer Sets, Reservoir Bag (FDA Code: BTC), Tubing & Connectors, ...
Uresil, LLC is a medical device development, manufacturing and distribution company that serves the needs of physicians who perform minimally invasive procedures. Our products are categorized into int more...
www.uresil.com | Send Inquiry | Phone: +1-(847)-982-0200, 800-538-7374
FDA Registration: 1450395 Year Established: 1986 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO 9002 Certified
Products: Drainage Catheter, Adhesive Bandages (FDA Code: KGX), Surgical Retractor Systems (FDA Code: GAD), Introducer Sets, Reservoir Bag (FDA Code: BTC), Tubing & Connectors, ...
Uresil, LLC is a medical device development, manufacturing and distribution company that serves the needs of physicians who perform minimally invasive procedures. Our products are categorized into int more...
Vitalcor, Inc. | Address: 100 East Chestnut Avenue, Westmont, Illinois 60559, USA
www.vitalcor.com | Send Inquiry | Phone: +1-(630)-325-5500, 800-874-8358
FDA Registration: 1450019 Year Established: 1975 Annual Revenues: USD 1-5 Million Quality: CE Certified
Products: Vascular Clamps (FDA Code: DXC), Surgical Retractor Systems (FDA Code: GAD), Sternal Retractor, Artery Vascular Clamp (FDA Code: DXC), Surgical Retractor (FDA Code: GAD), Cardiopulmonary Bypass Blood Reservoir (FDA Code: DTN), ...
Vitalcor, Inc. manufactures and distributes medical devices used primarily in cardio-thoracic surgery. We specialize in coronary artery perfusion cannulae with balloon. The balloon is made of self-inf more...
www.vitalcor.com | Send Inquiry | Phone: +1-(630)-325-5500, 800-874-8358
FDA Registration: 1450019 Year Established: 1975 Annual Revenues: USD 1-5 Million Quality: CE Certified
Products: Vascular Clamps (FDA Code: DXC), Surgical Retractor Systems (FDA Code: GAD), Sternal Retractor, Artery Vascular Clamp (FDA Code: DXC), Surgical Retractor (FDA Code: GAD), Cardiopulmonary Bypass Blood Reservoir (FDA Code: DTN), ...
Vitalcor, Inc. manufactures and distributes medical devices used primarily in cardio-thoracic surgery. We specialize in coronary artery perfusion cannulae with balloon. The balloon is made of self-inf more...
Precision Medical Manufacturing Corporation | Address: 852 Seton Court, Wheeling, Illinois 60090, USA
www.precisionmm.com | Send Inquiry | Phone: +1-(847)-229-1551, 866-633-4626
FDA Registration: 1416666 Year Established: 1914 Employee Count: ~20
Products: Vaginal Retractors (FDA Code: HDL), Self-Retaining Retractors (FDA Code: FFO), Surgical Retractor Systems (FDA Code: GAD), Neurosurgical Head Holder (FDA Code: HBL), Bone Mallets (FDA Code: HXL), Tonsil Snares (FDA Code: KBZ), ...
Precision Medical Manufacturing Corporation specializes in offering various medical devices. Our products include manual retractor, metal vaginal speculum, neurosurgical head holder, self-retaining re more...
www.precisionmm.com | Send Inquiry | Phone: +1-(847)-229-1551, 866-633-4626
FDA Registration: 1416666 Year Established: 1914 Employee Count: ~20
Products: Vaginal Retractors (FDA Code: HDL), Self-Retaining Retractors (FDA Code: FFO), Surgical Retractor Systems (FDA Code: GAD), Neurosurgical Head Holder (FDA Code: HBL), Bone Mallets (FDA Code: HXL), Tonsil Snares (FDA Code: KBZ), ...
Precision Medical Manufacturing Corporation specializes in offering various medical devices. Our products include manual retractor, metal vaginal speculum, neurosurgical head holder, self-retaining re more...
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FDA Code / Regulation: GAD / 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.
