General & Plastic Surgery Forceps Suppliers
Limit companies to: Worldwide USA
Erbrich Instrumente GmbH | Address: Eugenstraße 33, Tuttlingen-Nendingen D-78532, Germany 
www.erbrich-instruments.com | Send Inquiry | Phone: +49-(7461)-965730
Products: Suction Catheter and Tip (FDA Code: JOL), External Pelvimeter (FDA Code: HER), Ear Suction Tube (FDA Code: JZF), Sinus Trocar (FDA Code: KBG), Tonsil Suction Tube (FDA Code: KCB), Tracheal Trocar (FDA Code: KCI), ...
Erbrich Instrumente GmbH produces and distributes surgical instruments as well as instruments for veterinary medicine. We offer surgical instruments for neurosurgery, urology, gynecology obstetrics, b more...
www.erbrich-instruments.com | Send Inquiry | Phone: +49-(7461)-965730
Products: Suction Catheter and Tip (FDA Code: JOL), External Pelvimeter (FDA Code: HER), Ear Suction Tube (FDA Code: JZF), Sinus Trocar (FDA Code: KBG), Tonsil Suction Tube (FDA Code: KCB), Tracheal Trocar (FDA Code: KCI), ...
Erbrich Instrumente GmbH produces and distributes surgical instruments as well as instruments for veterinary medicine. We offer surgical instruments for neurosurgery, urology, gynecology obstetrics, b more...
Reinhold Narr | Address: Bruhlweg 2, Wehingen 78564, Germany
Phone: +49-(7426)-1450
Products: Nasal Scissors Straight (FDA Code: KBD), Nasal Scissors (FDA Code: KBD), ENT Forceps (FDA Code: KAE), General & Plastic Surgery Forceps (FDA Code: GEN), Surgical Stripper (FDA Code: HRT), Sterile Gelfoam Punch (FDA Code: JXZ), ...
Reinhold Narr provides products such as awl, plastic surgical hook, orthopedic manual surgical instrument, ENT forceps, nasal scissors and surgical strippers. more...
Phone: +49-(7426)-1450
Products: Nasal Scissors Straight (FDA Code: KBD), Nasal Scissors (FDA Code: KBD), ENT Forceps (FDA Code: KAE), General & Plastic Surgery Forceps (FDA Code: GEN), Surgical Stripper (FDA Code: HRT), Sterile Gelfoam Punch (FDA Code: JXZ), ...
Reinhold Narr provides products such as awl, plastic surgical hook, orthopedic manual surgical instrument, ENT forceps, nasal scissors and surgical strippers. more...
Werner Harfmann Gmbh | Address: Schwalbenweg 3, Wurmlingen 78573, Germany
Phone: +49-(7461)-75995
FDA Registration: 8010569
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), General & Plastic Surgery Forceps (FDA Code: GEN), Disposable Medical Scissors (FDA Code: JOK), Non-Powered Surgical Instrument (FDA Code: HAO), ...
Werner Harfmann Gmbh offers disposable medical scissors, gastroenterologic needle holder, general & plastic surgery forceps and non-powered surgical instruments. more...
Phone: +49-(7461)-75995
FDA Registration: 8010569
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), General & Plastic Surgery Forceps (FDA Code: GEN), Disposable Medical Scissors (FDA Code: JOK), Non-Powered Surgical Instrument (FDA Code: HAO), ...
Werner Harfmann Gmbh offers disposable medical scissors, gastroenterologic needle holder, general & plastic surgery forceps and non-powered surgical instruments. more...
Guenter Stoffel Medizintechnik Gmbh | Address: Kantstr. 37, Wurmlingen D-78573, Germany
www.insto.de | Send Inquiry | Phone: +49-(7461)-5890
FDA Registration: 8010370 Quality: ISO 13485, CE mark Certified
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Clamp (FDA Code: HXD), Scalpel Blade (FDA Code: GES), Endomyocardial Biopsy Device (FDA Code: DWZ), General Surgical Manual Instrument (FDA Code: MDM), Orthopedic Manual Surgical Instrument (FDA Code: LXH), ...
Guenter Stoffel Medizintechnik Gmbh offers instruments for micro-surgery and endoscopy. Our product line includes biopsy forceps, scissors, tweezers, needle & blade holders, flexible endoscopy biopsy more...
www.insto.de | Send Inquiry | Phone: +49-(7461)-5890
FDA Registration: 8010370 Quality: ISO 13485, CE mark Certified
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Clamp (FDA Code: HXD), Scalpel Blade (FDA Code: GES), Endomyocardial Biopsy Device (FDA Code: DWZ), General Surgical Manual Instrument (FDA Code: MDM), Orthopedic Manual Surgical Instrument (FDA Code: LXH), ...
Guenter Stoffel Medizintechnik Gmbh offers instruments for micro-surgery and endoscopy. Our product line includes biopsy forceps, scissors, tweezers, needle & blade holders, flexible endoscopy biopsy more...
Allsurg Medizintechnik UG | Address: Bachstr 8,, County Is Tuttlingen, Wurmlingen 78573, Germany
Phone: +49-(7461)-9107211
Products: Bone Clamp (FDA Code: HXD), General & Plastic Surgery Forceps (FDA Code: GEN), General & Plastic Surgery Surgical Mallet (FDA Code: GFJ), Metal Vaginal Speculum (FDA Code: HDF), Curettes (FDA Code: HTF), ENT Mirror (FDA Code: KAI), ...
Allsurg Medizintechnik UG provides medical supplies. more...
Phone: +49-(7461)-9107211
Products: Bone Clamp (FDA Code: HXD), General & Plastic Surgery Forceps (FDA Code: GEN), General & Plastic Surgery Surgical Mallet (FDA Code: GFJ), Metal Vaginal Speculum (FDA Code: HDF), Curettes (FDA Code: HTF), ENT Mirror (FDA Code: KAI), ...
Allsurg Medizintechnik UG provides medical supplies. more...
Rainer Rosenkranz Chirurgische Instrumente | Address: Stockacher Str. 128, Tuttlingen, Baden Wurttemberg 78532, Germany
Phone: +49-(7461)-3877
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Forceps Needle Holders, Stainless Steel Needle Holders, Micro Needle Holder, Hexagonal Needle Holder, Triangle Needle Holder, ...
Rainer Rosenkranz Chirurgische Instrumente is a provider of wire cutter, needle holder, various forceps and surgical products. more...
Phone: +49-(7461)-3877
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Forceps Needle Holders, Stainless Steel Needle Holders, Micro Needle Holder, Hexagonal Needle Holder, Triangle Needle Holder, ...
Rainer Rosenkranz Chirurgische Instrumente is a provider of wire cutter, needle holder, various forceps and surgical products. more...
Gimmi GmbH | Address: Carl-Zeiss-Strasse 6, Tuttlingen, Baden-Wuerttemberg D-78532, Germany
www.gimmi.de | Send Inquiry | Phone: +49-(7461)-96 590-0
FDA Registration: 3010607620 Annual Revenues: < USD 1 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Yasargil Aneurysm Clips, Cystoscopes, Surgical Instrument (Miscellaneous Medical), Laparoscopy, Laparoscopes, Hysteroscope Diagnosing System, Electrosurgical Accessories, Bipolar Coagulation Forceps, ...
Gimmi GmbH manufactures and distributes medical products. We specialize in instruments & equipment for endoscopy. Our product line ranges from instruments for general surgery to our developed endoscop more...
www.gimmi.de | Send Inquiry | Phone: +49-(7461)-96 590-0
FDA Registration: 3010607620 Annual Revenues: < USD 1 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Yasargil Aneurysm Clips, Cystoscopes, Surgical Instrument (Miscellaneous Medical), Laparoscopy, Laparoscopes, Hysteroscope Diagnosing System, Electrosurgical Accessories, Bipolar Coagulation Forceps, ...
Gimmi GmbH manufactures and distributes medical products. We specialize in instruments & equipment for endoscopy. Our product line ranges from instruments for general surgery to our developed endoscop more...
Ustomed Instrumente - Ulrich Storz Gmbh & Co. Kg | Address: Am Eichbuhl 70-72, Tuttlingen, BW 78532, Germany
www.ustomed.de | Send Inquiry | Phone: +49-(7461)-965-85-0
Annual Revenues: USD 5-10 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Bone Rasps (FDA Code: HTR), Obstetrical Forceps (FDA Code: HDA), Intramedullary Bone Rasps, Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Nasal Rasps (FDA Code: KBA), ...
Ustomed Instrumente - Ulrich Storz Gmbh & Co. Kg specializes in the manufacture and sale of dental and surgical instruments. We provide instruments for dentists, oral and maxillofacial surgeons, impla more...
www.ustomed.de | Send Inquiry | Phone: +49-(7461)-965-85-0
Annual Revenues: USD 5-10 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Bone Rasps (FDA Code: HTR), Obstetrical Forceps (FDA Code: HDA), Intramedullary Bone Rasps, Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Nasal Rasps (FDA Code: KBA), ...
Ustomed Instrumente - Ulrich Storz Gmbh & Co. Kg specializes in the manufacture and sale of dental and surgical instruments. We provide instruments for dentists, oral and maxillofacial surgeons, impla more...
MAT | Address: Friedrich-Woehler-Str. 10, Emmingen-Liptingen, DE-BW 78576, Germany
www.mat-medical.com | Send Inquiry | Phone: +49-(7465)-909 188
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Instrument Tray (FDA Code: FSM), Endoscopic Television Camera (FDA Code: FWG), Endoscopic Television Camera without Audio (FDA Code: FWF), Manual Surgical Chisel (FDA Code: FZO), Non-Electric Biopsy Forceps (FDA Code: FCL), ...
MAT designs, develops, and manufactures implants for implant systems. We make orthopedic implants used primarily in knee and hip implant systems. We provide a broad range of trauma and dental implants more...
www.mat-medical.com | Send Inquiry | Phone: +49-(7465)-909 188
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Instrument Tray (FDA Code: FSM), Endoscopic Television Camera (FDA Code: FWG), Endoscopic Television Camera without Audio (FDA Code: FWF), Manual Surgical Chisel (FDA Code: FZO), Non-Electric Biopsy Forceps (FDA Code: FCL), ...
MAT designs, develops, and manufactures implants for implant systems. We make orthopedic implants used primarily in knee and hip implant systems. We provide a broad range of trauma and dental implants more...
BAK Kohler Medizintechnik Gmbh | Address: Siemensring 15, Neuhausen Ob Eck, DE-BW 78579, Germany
www.kohler-med.de
FDA Registration: 8043548
Products: Catheter Accessories (FDA Code: KGZ), General & Plastic Surgery Forceps (FDA Code: GEN), General & Plastic Surgery Laparoscope (FDA Code: GCJ), General & Plastic Surgery Surgical Dissector (FDA Code: GDI), Surgical Needle Guide (FDA Code: GDF), Gynecologic Laparoscope and Accessories (FDA Code: HET), ...
BAK Kohler Medizintechnik Gmbh specializes in surgical instruments. Our product line includes scissors, pliers, endoscopes, retractors, bone implants, oscillating tools, and suction or irrigation inst more...
www.kohler-med.de
FDA Registration: 8043548
Products: Catheter Accessories (FDA Code: KGZ), General & Plastic Surgery Forceps (FDA Code: GEN), General & Plastic Surgery Laparoscope (FDA Code: GCJ), General & Plastic Surgery Surgical Dissector (FDA Code: GDI), Surgical Needle Guide (FDA Code: GDF), Gynecologic Laparoscope and Accessories (FDA Code: HET), ...
BAK Kohler Medizintechnik Gmbh specializes in surgical instruments. Our product line includes scissors, pliers, endoscopes, retractors, bone implants, oscillating tools, and suction or irrigation inst more...
Tontarra Medizintechnik Gmbh | Address: Daimlerstrasse 15, Wurmlingen, DE-BW D-78573, Germany
FDA Registration: 9680515
Products: Nasal Scissors Straight (FDA Code: KBD), Nasal Punch (FDA Code: KAY), Nasal Scissors (FDA Code: KBD), Rib Rongeurs (FDA Code: HTX), Mastoid Rongeurs (FDA Code: JZA), ENT Forceps (FDA Code: KAE), ...
Tontarra Medizintechnik Gmbh is a provider of surgical instruments. more...
FDA Registration: 9680515
Products: Nasal Scissors Straight (FDA Code: KBD), Nasal Punch (FDA Code: KAY), Nasal Scissors (FDA Code: KBD), Rib Rongeurs (FDA Code: HTX), Mastoid Rongeurs (FDA Code: JZA), ENT Forceps (FDA Code: KAE), ...
Tontarra Medizintechnik Gmbh is a provider of surgical instruments. more...
CM Instrumente GmbH | Address: Im Gänsäcker 56, Tuttlingen, Deutschland 78532, Germany
www.cm-instrumente.de | Send Inquiry | Phone: +49-(7462)-2042070
FDA Registration: 9680518
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ...
Cm Instrumente Gmbh is a manufacturer and distributor of surgical instruments & surgical implants. Our surgical instruments include osteosynthesis, aluminum rib spreaders, atraumatic cardiovascular cl more...
www.cm-instrumente.de | Send Inquiry | Phone: +49-(7462)-2042070
FDA Registration: 9680518
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ...
Cm Instrumente Gmbh is a manufacturer and distributor of surgical instruments & surgical implants. Our surgical instruments include osteosynthesis, aluminum rib spreaders, atraumatic cardiovascular cl more...
Kuhn Medizintechnik | Address: IN POND acres 2, Duerbheim, Kr Tuttlingen 78589, Germany
Send Inquiry | Phone: +49-(7424)-2554
Quality: ISO 9001 Certified
Products: General & Plastic Surgery Forceps (FDA Code: GEN), Orthopedic Manual Surgical Instrument (FDA Code: LXH), ...
Kuhn Medizintechnik specializes in the manufacture of bone cutting forceps, bone rongeurs and devices for bone surgery. more...
Send Inquiry | Phone: +49-(7424)-2554
Quality: ISO 9001 Certified
Products: General & Plastic Surgery Forceps (FDA Code: GEN), Orthopedic Manual Surgical Instrument (FDA Code: LXH), ...
Kuhn Medizintechnik specializes in the manufacture of bone cutting forceps, bone rongeurs and devices for bone surgery. more...
Kapp Surgical GmbH | Address: Hauptstr 5, Duerbheim, Kr Tuttlingen 78589, Germany
www.kapp-germany.de | Send Inquiry | Phone: +49-(7424)-94-03-0
FDA Registration: 8010769 Year Established: 1982 Quality: ISO 9001, CE Certified
Products: Wire Twisters (FDA Code: HXS), Automatic Wire Twisters, Surgical Instruments, Wire Twisters, Sternal Wire Twister, Rib Rongeurs (FDA Code: HTX), General & Plastic Surgery Forceps (FDA Code: GEN), ...
Kapp Surgical GmbH offers surgical products such as laminectomy rongeurs, intervertebral ronguers, jaws, bone rongeurs, bone cutting forceps, and wire cutting pliers. more...
www.kapp-germany.de | Send Inquiry | Phone: +49-(7424)-94-03-0
FDA Registration: 8010769 Year Established: 1982 Quality: ISO 9001, CE Certified
Products: Wire Twisters (FDA Code: HXS), Automatic Wire Twisters, Surgical Instruments, Wire Twisters, Sternal Wire Twister, Rib Rongeurs (FDA Code: HTX), General & Plastic Surgery Forceps (FDA Code: GEN), ...
Kapp Surgical GmbH offers surgical products such as laminectomy rongeurs, intervertebral ronguers, jaws, bone rongeurs, bone cutting forceps, and wire cutting pliers. more...
Hermann Medizintechnik GmbH | Address: Wurttemberger Straße 26, Fridingen, Kreis Tuttlingen 78567, Germany
www.hermann-medizintechnik.de | Send Inquiry | Phone: +49-(7463)-9967-0
FDA Registration: 8010257 Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Retractors, Scissors, Gastroenterologic Needle Holder (FDA Code: FHQ), Sterilizing Aids, ...
Hermann Medizintechnik GmbH manufactures surgical instruments, implants and equipment. Our product line comprises of titanium implant systems, laparoscopy, arthroscopy, electrosurgery, endoscopic unit more...
www.hermann-medizintechnik.de | Send Inquiry | Phone: +49-(7463)-9967-0
FDA Registration: 8010257 Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Retractors, Scissors, Gastroenterologic Needle Holder (FDA Code: FHQ), Sterilizing Aids, ...
Hermann Medizintechnik GmbH manufactures surgical instruments, implants and equipment. Our product line comprises of titanium implant systems, laparoscopy, arthroscopy, electrosurgery, endoscopic unit more...
Geister Medizintechnik GmbH | Address: Föhrenstrasse 2, Tuttlingen D-78532, Germany
www.geister.com | Send Inquiry | Phone: +49-(7461)-966240
FDA Registration: 8010697 Quality: DIN ISO 9001, ISO 13485 Certified
Products: Anastomosis Clamps, Abdominal Retractor, Aluminium Retractors, Atrial Retractors, Adventitia Scissors, Abdominal Frame Retractor System, ...
Geister Medizintechnik GmbH is a manufacturer of specialized surgical products carrying a full range of advanced surgical instruments and devices. We work in the three business fields such as cardio, more...
www.geister.com | Send Inquiry | Phone: +49-(7461)-966240
FDA Registration: 8010697 Quality: DIN ISO 9001, ISO 13485 Certified
Products: Anastomosis Clamps, Abdominal Retractor, Aluminium Retractors, Atrial Retractors, Adventitia Scissors, Abdominal Frame Retractor System, ...
Geister Medizintechnik GmbH is a manufacturer of specialized surgical products carrying a full range of advanced surgical instruments and devices. We work in the three business fields such as cardio, more...
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: Forceps (FDA Code: HTD), Kerrison Punches, Laryngeal Mirrors, Nasal & Ear Specula, Biopsy Forceps, Internal Jugular Approach 7, Alligator Forceps, ...
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: Forceps (FDA Code: HTD), Kerrison Punches, Laryngeal Mirrors, Nasal & Ear Specula, Biopsy Forceps, Internal Jugular Approach 7, Alligator Forceps, ...
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: Bipolar Forceps, Reusable Bipolar Forceps, Microsurgical Bipolar Forceps, Titanium Bipolar Forceps (Ophthalmology), Bipolar Forceps, Handswitching, Flexible Depth Gauge (FDA Code: HTJ), ...
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: Bipolar Forceps, Reusable Bipolar Forceps, Microsurgical Bipolar Forceps, Titanium Bipolar Forceps (Ophthalmology), Bipolar Forceps, Handswitching, Flexible Depth Gauge (FDA Code: HTJ), ...
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: Nasal Rasps (FDA Code: KBA), Adjustable Frequency Tuning Fork, Hertz Frequency Tuning Fork, Sensory Evaluation Tuning Fork, Aluminium Tuning Fork, Magnesium Tuning Forks, ...
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: Nasal Rasps (FDA Code: KBA), Adjustable Frequency Tuning Fork, Hertz Frequency Tuning Fork, Sensory Evaluation Tuning Fork, Aluminium Tuning Fork, Magnesium Tuning Forks, ...
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...
Lanques Medical | Address: La Forge Du Bas, Lanques Sur Rognon 52800, France
Phone: +33-(253)-198-93
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Forceps Needle Holders, Micro Needle Holder, Hexagonal Needle Holder, Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), ...
Lanques Medical deals with curettes, metal vaginal speculum, surgical retractors, surgical punches, needle holders, and scissors. more...
Phone: +33-(253)-198-93
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Forceps Needle Holders, Micro Needle Holder, Hexagonal Needle Holder, Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), ...
Lanques Medical deals with curettes, metal vaginal speculum, surgical retractors, surgical punches, needle holders, and scissors. more...
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FDA Code / Regulation: GEN / 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.
