Surgical Retractor Suppliers
Limit companies to: Worldwide USA
Tekno-medical Optik-Chirurgie GmbH & Co KG. | Address: Sattlerstrasse 11, Tuttlingen D-78532, Germany 
www.tekno-medical.com | Send Inquiry | Phone: +49-(7461)-1701-0
Annual Revenues: USD 5-10 Million Employee Count: ~50 Quality: ISO 9001, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Double Prong Skin Hooks, Single Prong Skin Hooks, Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), ...
Tekno-medical Optik-Chirurgie GmbH & Co KG. specializes in surgery, endoscopy, ENT, H-F surgery, and dental instruments. We also focus on the supply of different medical articles. Our product catalogu more...
www.tekno-medical.com | Send Inquiry | Phone: +49-(7461)-1701-0
Annual Revenues: USD 5-10 Million Employee Count: ~50 Quality: ISO 9001, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Double Prong Skin Hooks, Single Prong Skin Hooks, Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), ...
Tekno-medical Optik-Chirurgie GmbH & Co KG. specializes in surgery, endoscopy, ENT, H-F surgery, and dental instruments. We also focus on the supply of different medical articles. Our product catalogu more...
Jakoubek | Address: Auf der Höhe 15, Liptingen, Tuttlingen D-78576, Germany
www.jakoubek.com | Send Inquiry | Phone: +49-(7465)-9264-0
FDA Registration: 9612277
Products: Probes (FDA Code: HXB), Bipolar Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Arthroscopes (FDA Code: HRX), Surgical Retractor Systems (FDA Code: GAD), Reusable Bipolar Forceps, ...
Jakoubek supplies advanced surgical equipment. Our flexible gastro-intestinal product line comprises of biopsy forceps, probes, catheter and stone removal forceps. Our laparoscopy product line compris more...
www.jakoubek.com | Send Inquiry | Phone: +49-(7465)-9264-0
FDA Registration: 9612277
Products: Probes (FDA Code: HXB), Bipolar Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Arthroscopes (FDA Code: HRX), Surgical Retractor Systems (FDA Code: GAD), Reusable Bipolar Forceps, ...
Jakoubek supplies advanced surgical equipment. Our flexible gastro-intestinal product line comprises of biopsy forceps, probes, catheter and stone removal forceps. Our laparoscopy product line compris more...
Etablissements Boutmy S.A. | Address: Saint Aubin Le Monial, Rue Le Pavillon, Bourbon L Archambault 03160, France
Phone: +33-(70)-67-0451
FDA Registration: 9680837
Products: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, ...
Etablissements Boutmy S.A. specializes in offering disposable and implantable products. Our products include obstetric and gynecologic general manual instruments, tongue depressor, various needle hold more...
Phone: +33-(70)-67-0451
FDA Registration: 9680837
Products: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, ...
Etablissements Boutmy S.A. specializes in offering disposable and implantable products. Our products include obstetric and gynecologic general manual instruments, tongue depressor, various needle hold more...
Neuro France Implants | Address: Les Blanchetieres, Boursay 41270, France
www.neuro-france.net | Send Inquiry | Phone: +33-(254)-80 90 90
Products: Surgical Retractor Systems (FDA Code: GAD), Rib Rongeurs (FDA Code: HTX), Implantable Stimulation Leads for Neuromodulation Applications, Stand Alone Anterior Fusion Cage, Thoracolumbar Support, Surgical Retractor (FDA Code: GAD), ...
Neuro France Implants specializes in the development of implants to correct spinal column defects. We offer implants such as thoraco-lumbar and cervical range, for anterior and posterior fixation & in more...
www.neuro-france.net | Send Inquiry | Phone: +33-(254)-80 90 90
Products: Surgical Retractor Systems (FDA Code: GAD), Rib Rongeurs (FDA Code: HTX), Implantable Stimulation Leads for Neuromodulation Applications, Stand Alone Anterior Fusion Cage, Thoracolumbar Support, Surgical Retractor (FDA Code: GAD), ...
Neuro France Implants specializes in the development of implants to correct spinal column defects. We offer implants such as thoraco-lumbar and cervical range, for anterior and posterior fixation & in more...
Depuy France S.A. | Address: Z I La Vendue Bp88, Chaumont, France
Phone: +33-(219)-267-8143
FDA Registration: 9615674
Products: Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Intramedullary Bone Rasps, Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Drill Bit (FDA Code: HTW), ...
Depuy France S.A. specializes in the designing and manufacturing of orthopedic devices. Our products include trauma products, implants and technologies for hips, knees, ankles, shoulders & wrists, mod more...
Phone: +33-(219)-267-8143
FDA Registration: 9615674
Products: Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Intramedullary Bone Rasps, Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Drill Bit (FDA Code: HTW), ...
Depuy France S.A. specializes in the designing and manufacturing of orthopedic devices. Our products include trauma products, implants and technologies for hips, knees, ankles, shoulders & wrists, mod more...
Medicrea | Address: Z.I. Chef De Baie, La Rochelle 17000, France
FDA Registration: 1000432246
Products: 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), Drill Bit (FDA Code: HTW), ...
Medicrea supplies surgical, orthopedic and spinal products. Our products include lumbar intervertebral fusion devices with bone grafts, spinal interlaminal fixation appliances, spondylolisthesis spina more...
FDA Registration: 1000432246
Products: 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), Drill Bit (FDA Code: HTW), ...
Medicrea supplies surgical, orthopedic and spinal products. Our products include lumbar intervertebral fusion devices with bone grafts, spinal interlaminal fixation appliances, spondylolisthesis spina more...
Lanques Medical | Address: La Forge Du Bas, Lanques Sur Rognon 52800, France
Phone: +33-(253)-198-93
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Forceps Needle Holders, Stainless Steel Needle Holders, Tungsten Carbide Needle Holders, Micro Needle Holder, ...
Lanques Medical deals with curettes, metal vaginal speculum, surgical retractors, surgical punches, needle holders, and scissors. more...
Phone: +33-(253)-198-93
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Forceps Needle Holders, Stainless Steel Needle Holders, Tungsten Carbide Needle Holders, Micro Needle Holder, ...
Lanques Medical deals with curettes, metal vaginal speculum, surgical retractors, surgical punches, needle holders, and scissors. more...
Lifecare Surgical | Address: Nasr City Free Industrial Zone, Area 3, Block B, Nasr City 11816, Egypt
www.lifecaresi.com | Send Inquiry | Phone: +20-(2)-26720314
Quality: ISO 13485:2003 Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), Bone Hooks (FDA Code: KIK), ...
Lifecare Surgical focuses on general surgical, dental, veterinary, and electro surgical instruments. We provide knives, scalpels, suture, forceps, probes, spatula, cotton carriers, suction tubes, and more...
www.lifecaresi.com | Send Inquiry | Phone: +20-(2)-26720314
Quality: ISO 13485:2003 Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), Bone Hooks (FDA Code: KIK), ...
Lifecare Surgical focuses on general surgical, dental, veterinary, and electro surgical instruments. We provide knives, scalpels, suture, forceps, probes, spatula, cotton carriers, suction tubes, and more...
Allegiance Healthcare Corp. | Address: Zona Franca Las Americas, Autlas Americas Km 22 1-2 Sur, Santo Domingo, Dominican Republic
Phone: 847-473-1500
FDA Registration: 9680904
Products: Oxygen Masks (FDA Code: BYG), Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), ...
Allegiance Healthcare Corp are providers of introducer needle reusables, disposable bome marrow biopsy needles and trays. more...
Phone: 847-473-1500
FDA Registration: 9680904
Products: Oxygen Masks (FDA Code: BYG), Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), ...
Allegiance Healthcare Corp are providers of introducer needle reusables, disposable bome marrow biopsy needles and trays. more...
Davis And Geck Caribe, Ltd. | Address: Zona Franca De San Isidro, Carretara San Isidro Km 17, Santo Domingo, Dominican Republic
Phone: 203-845-1000
FDA Registration: 9612501
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Catheter Introducers (FDA Code: DYB), Arthroscopes (FDA Code: HRX), Catheter Stylets (FDA Code: DRB), Electrode Cables (FDA Code: IKD), ...
Davis And Geck Caribe, Ltd. specializes in the production of polytetrafluorethylene pledget, disposable endoscopic specimen pouch, steel sutures and umbilical tape-sterile round cotton tape. more...
Phone: 203-845-1000
FDA Registration: 9612501
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Catheter Introducers (FDA Code: DYB), Arthroscopes (FDA Code: HRX), Catheter Stylets (FDA Code: DRB), Electrode Cables (FDA Code: IKD), ...
Davis And Geck Caribe, Ltd. specializes in the production of polytetrafluorethylene pledget, disposable endoscopic specimen pouch, steel sutures and umbilical tape-sterile round cotton tape. more...
Lina Medical Aps | Address: Formervangen 5, Glostrup 2600, Denmark
www.lina-medical.com | Send Inquiry | Phone: +45-(4329)-6666
FDA Registration: 3002626775
Products: Catheter Accessories (FDA Code: KGZ), Adhesive Bandages (FDA Code: KGX), Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), General & Plastic Surgery Laparoscope (FDA Code: GCJ), ...
Lina Medical Aps specializes in devices for smoke evacuation and minimally invasive surgery for gynaecology & general surgery. Our smoke evacuation pencils include lina grey & white shark pencils. Our more...
www.lina-medical.com | Send Inquiry | Phone: +45-(4329)-6666
FDA Registration: 3002626775
Products: Catheter Accessories (FDA Code: KGZ), Adhesive Bandages (FDA Code: KGX), Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), General & Plastic Surgery Laparoscope (FDA Code: GCJ), ...
Lina Medical Aps specializes in devices for smoke evacuation and minimally invasive surgery for gynaecology & general surgery. Our smoke evacuation pencils include lina grey & white shark pencils. Our more...
Huaian Wolfram Surgical Instruments Co. Ltd | Address: 14 Xujiahu Road, Huaian 223002, China 
Phone: +86-(517)-3981533
FDA Registration: 3003803182
Products: Surgical Retractor Systems (FDA Code: GAD), Microsurgical Instruments (FDA Code: GZX), Cardiovascular Surgical Instrument (FDA Code: DWS), Ophthalmic Suture Scissors (FDA Code: HNF), Ophthalmic Forceps (FDA Code: HNR), Surgical Retractor (FDA Code: GAD), ...
Huaian Wolfram Surgical Instruments Co. Ltd is a manufacturer of various types of surgical instruments. more...
Phone: +86-(517)-3981533
FDA Registration: 3003803182
Products: Surgical Retractor Systems (FDA Code: GAD), Microsurgical Instruments (FDA Code: GZX), Cardiovascular Surgical Instrument (FDA Code: DWS), Ophthalmic Suture Scissors (FDA Code: HNF), Ophthalmic Forceps (FDA Code: HNR), Surgical Retractor (FDA Code: GAD), ...
Huaian Wolfram Surgical Instruments Co. Ltd is a manufacturer of various types of surgical instruments. more...
Shanghai C-Top Precision Machinery Manufacture Co. | Address: 15no. Dong Ping Road, Room 511, Shanghai 200031, China
www.shanghai-ctop.com.cn | Send Inquiry | Phone: +86-(21)-64159102
Quality: ISO9001:2000 Certified
Products: Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Tamps (FDA Code: HXG), Rib Rongeurs (FDA Code: HTX), ...
Shanghai C-Top Precision Machinery Manufacture Co. offers medical apparatus and instruments. more...
www.shanghai-ctop.com.cn | Send Inquiry | Phone: +86-(21)-64159102
Quality: ISO9001:2000 Certified
Products: Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Tamps (FDA Code: HXG), Rib Rongeurs (FDA Code: HTX), ...
Shanghai C-Top Precision Machinery Manufacture Co. offers medical apparatus and instruments. more...
Shanghai Multi-Med Union Co., Ltd. | Address: 20/F,1958 Zhongshan North Road, Shanghai 200063, China
www.multi-med.cn | Phone: +86-(21)-62032122
FDA Registration: 3006477134
Products: Forceps (FDA Code: HTD), Scissors, Face Masks, Sphygmomanometers, Blood Pressure Monitors, Digital Thermometers, ...
Shanghai Multi-Med Union Co., Ltd specializes in the production instruments for surgeries and diagnostics. Our product line comprises of laboratory & dental products, surgical dressings, non-woven fac more...
www.multi-med.cn | Phone: +86-(21)-62032122
FDA Registration: 3006477134
Products: Forceps (FDA Code: HTD), Scissors, Face Masks, Sphygmomanometers, Blood Pressure Monitors, Digital Thermometers, ...
Shanghai Multi-Med Union Co., Ltd specializes in the production instruments for surgeries and diagnostics. Our product line comprises of laboratory & dental products, surgical dressings, non-woven fac more...
Xinhua Surgical Instrument Co. Ltd. | Address: No. 7 Taimei Road, Zibo New And Hi-Tech Development Zone, Zibo 255086, China
www.xinhuasurgical.com | Phone: +86-(0533)-3595351
FDA Registration: 3005440795
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), ...
Xinhua Surgical Instrument Company Ltd. manufactures surgical instruments. Our products include dental instruments, veterinary instruments, sterilizers, autoclaves and dressing containers, electric su more...
www.xinhuasurgical.com | Phone: +86-(0533)-3595351
FDA Registration: 3005440795
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), ...
Xinhua Surgical Instrument Company Ltd. manufactures surgical instruments. Our products include dental instruments, veterinary instruments, sterilizers, autoclaves and dressing containers, electric su more...
Zhejiang Biomet Medical Products Co., Ltd. | Address: No.318, Qiu Tao North Street, Jinhua Industrial Zone, Jinhua, Zhejiang 321016, China
www.biomet.com | Phone: +86-(579)-227-3055
FDA Registration: 3006801265
Products: Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Bone Mallets (FDA Code: HXL), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), ...
Zhejiang Biomet Medical Products Co., Ltd. offers orthopedic and arthritis products. Our Oxford™ partial knee implant is an implant designed to repair only one side of the knee. Our product remo more...
www.biomet.com | Phone: +86-(579)-227-3055
FDA Registration: 3006801265
Products: Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Bone Mallets (FDA Code: HXL), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), ...
Zhejiang Biomet Medical Products Co., Ltd. offers orthopedic and arthritis products. Our Oxford™ partial knee implant is an implant designed to repair only one side of the knee. Our product remo more...
Jac-Cell Medic | Address: 1847 32nd Avenue, Lachine, Quebec H8T 3J1, Canada 
www.jaccell.com | Send Inquiry | Phone: +1-(514)-631-8806
FDA Registration: 3003008746
Products: Saws (FDA Code: HSO), Scalpels, Scissors, Surgical Retractor Systems (FDA Code: GAD), Bone Mallets (FDA Code: HXL), Cannulas, ...
Jac-Cell Medic supplies medical and surgical instruments & disposable devices to physicians & health care institutions. Our medical and surgical instruments include cannula, scissors, tumescent autofu more...
www.jaccell.com | Send Inquiry | Phone: +1-(514)-631-8806
FDA Registration: 3003008746
Products: Saws (FDA Code: HSO), Scalpels, Scissors, Surgical Retractor Systems (FDA Code: GAD), Bone Mallets (FDA Code: HXL), Cannulas, ...
Jac-Cell Medic supplies medical and surgical instruments & disposable devices to physicians & health care institutions. Our medical and surgical instruments include cannula, scissors, tumescent autofu more...
Bontempi International Inc. | Address: 331 Kindersley, Mont-Royal, Quebec H3R1R8, Canada
Phone: +1-(514)-739-4010
Products: Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Wire Cutters (FDA Code: HXZ), Nasal Chisel (FDA Code: KAN), ...
Bontempi International Inc. focuses on orthopedic products. We provide bone rasps, forceps, cannula, dissectors, hooks, rib rongeurs, surgical scissors and nasal chisels. more...
Phone: +1-(514)-739-4010
Products: Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Wire Cutters (FDA Code: HXZ), Nasal Chisel (FDA Code: KAN), ...
Bontempi International Inc. focuses on orthopedic products. We provide bone rasps, forceps, cannula, dissectors, hooks, rib rongeurs, surgical scissors and nasal chisels. more...
Coroneo, Inc. | Address: 9250 Avenue Du Parc, Suite 514, Montreal, Quebec H2N 1Z2, Canada
www.coroneo.com | Send Inquiry | Phone: +1-(514)-3369230
FDA Registration: 9616227 Year Established: 1997 Quality: ISO 13485:2003 Certified
Products: Surgical Retractor Systems (FDA Code: GAD), Cardiovascular Surgical Instrument (FDA Code: DWS), Surgical Snare (FDA Code: GAE), Surgical Retractor (FDA Code: GAD), ...
Coroneo, Inc. specializes in the research, development, and product commercialization of medical devices in the field of cardiac surgery. The extra-aortic annuloplasty ring, supports dystrophic aortic more...
www.coroneo.com | Send Inquiry | Phone: +1-(514)-3369230
FDA Registration: 9616227 Year Established: 1997 Quality: ISO 13485:2003 Certified
Products: Surgical Retractor Systems (FDA Code: GAD), Cardiovascular Surgical Instrument (FDA Code: DWS), Surgical Snare (FDA Code: GAE), Surgical Retractor (FDA Code: GAD), ...
Coroneo, Inc. specializes in the research, development, and product commercialization of medical devices in the field of cardiac surgery. The extra-aortic annuloplasty ring, supports dystrophic aortic more...
Oculo-Plastik, Inc. | Address: 200 Sauve West, Montreal, Quebec H3L 1Y9, Canada
www.oculoplastik.com | Send Inquiry | Phone: +1-(514)-381-3292
FDA Registration: 8022166 Annual Revenues: < USD 1 Million Employee Count: ~10 Quality: CE, ISO 9001:2000, ISO 13485:2003 Certified
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Symblepharon Rings, Castroviejo Calipers, Stevens Tenotomy Scissors, Enucleation Scissors, Jaeger Lid Plates, ...
Oculo-Plastik, Inc. manufactures and supplies products for the safe use of lasers. We deliver stainless steel shields and instruments. Our opsoft mouthguard is meant for protection during hair removal more...
www.oculoplastik.com | Send Inquiry | Phone: +1-(514)-381-3292
FDA Registration: 8022166 Annual Revenues: < USD 1 Million Employee Count: ~10 Quality: CE, ISO 9001:2000, ISO 13485:2003 Certified
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Symblepharon Rings, Castroviejo Calipers, Stevens Tenotomy Scissors, Enucleation Scissors, Jaeger Lid Plates, ...
Oculo-Plastik, Inc. manufactures and supplies products for the safe use of lasers. We deliver stainless steel shields and instruments. Our opsoft mouthguard is meant for protection during hair removal 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.
