Disposable Suture Needle Suppliers
Limit companies to: Worldwide USA
Marine Medical International | Address: 1414 South Andrews Avenue, Fort Lauderdale, Florida 33316, USA 
www.marmed.com | Send Inquiry | Phone: +1-(954)-523-1404
Year Established: 1998 Annual Revenues: < USD 1 Million
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Adhesive Bandages (FDA Code: KGX), Clinical Mercury Thermometers (FDA Code: FLK), First Aid Kit Boxes, OSHA Compliant, First Aid Kits, ...
Marine Medical International deals with medical kits, automatic external defibrillators (AEDs) and AED diagnostic kits. We also supply oxygen systems, bag-valve resuscitators, respirators, ventilators more...
www.marmed.com | Send Inquiry | Phone: +1-(954)-523-1404
Year Established: 1998 Annual Revenues: < USD 1 Million
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Adhesive Bandages (FDA Code: KGX), Clinical Mercury Thermometers (FDA Code: FLK), First Aid Kit Boxes, OSHA Compliant, First Aid Kits, ...
Marine Medical International deals with medical kits, automatic external defibrillators (AEDs) and AED diagnostic kits. We also supply oxygen systems, bag-valve resuscitators, respirators, ventilators 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...
Anchor Products Co., Inc. | Address: 52 Official Rd., Addison, Illinois 60101, USA
www.anchorsurgical.com | Send Inquiry | Phone: +1-(630)-543-9124, 800-323-5134
FDA Registration: 1416891 Year Established: 1925 Quality: ISO 9002, CE Certified
Products: Implant Knives, Slit Knives, Suture Needles, Scleral Blades, Surgical Needles, Reusable, Dental Needles, ...
Anchor Products Co., Inc. specializes in surgical products. Our product list comprises of soft tissue biopsy devices, sterile ophthalmic blades, postmortem needles, tissue retrieval system and dental more...
www.anchorsurgical.com | Send Inquiry | Phone: +1-(630)-543-9124, 800-323-5134
FDA Registration: 1416891 Year Established: 1925 Quality: ISO 9002, CE Certified
Products: Implant Knives, Slit Knives, Suture Needles, Scleral Blades, Surgical Needles, Reusable, Dental Needles, ...
Anchor Products Co., Inc. specializes in surgical products. Our product list comprises of soft tissue biopsy devices, sterile ophthalmic blades, postmortem needles, tissue retrieval system and dental 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...
Tornier Inc. | Address: 100 Cummings Center, Suite 444c, Beverly, Massachusetts 01915, USA
www.tornier-us.com | Send Inquiry | Phone: +1-(978)-232-9997, 800-611-2992
FDA Registration: 3004983210
Products: Bone Rasps (FDA Code: HTR), Surgical Mesh (FDA Code: FTM), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Wire Cutters (FDA Code: HXZ), Surgical Instrument Tray (FDA Code: FSM), ...
Tornier Inc. specializes in orthopedic industry. We offer a broad range of joint replacement products including hips, knees, shoulders, ankles, and other extremity prostheses. We provide prosthesis de more...
www.tornier-us.com | Send Inquiry | Phone: +1-(978)-232-9997, 800-611-2992
FDA Registration: 3004983210
Products: Bone Rasps (FDA Code: HTR), Surgical Mesh (FDA Code: FTM), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Wire Cutters (FDA Code: HXZ), Surgical Instrument Tray (FDA Code: FSM), ...
Tornier Inc. specializes in orthopedic industry. We offer a broad range of joint replacement products including hips, knees, shoulders, ankles, and other extremity prostheses. We provide prosthesis de more...
Lemaitre Vascular, Inc. | Address: 63 Second Avenue, Burlington, Massachusetts 01803, USA
www.lemaitre.com | Send Inquiry | Phone: +1-(781)-221-2266
FDA Registration: 1220948 Year Established: 1983 Annual Revenues: USD 25-50 Million Employee Count: ~250 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Surgical Mesh (FDA Code: FTM), Embolectomy Catheters (FDA Code: DXE), Adhesive Bandages (FDA Code: KGX), Temporary Microvascular Clips, Neurosurgery, Surgical Retractor Systems (FDA Code: GAD), ...
LeMaitre Vascular, Inc. is a global provider of devices for the treatment of peripheral vascular disease. We develop, manufacture, and market disposable & implantable vascular devices to address the n more...
www.lemaitre.com | Send Inquiry | Phone: +1-(781)-221-2266
FDA Registration: 1220948 Year Established: 1983 Annual Revenues: USD 25-50 Million Employee Count: ~250 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Surgical Mesh (FDA Code: FTM), Embolectomy Catheters (FDA Code: DXE), Adhesive Bandages (FDA Code: KGX), Temporary Microvascular Clips, Neurosurgery, Surgical Retractor Systems (FDA Code: GAD), ...
LeMaitre Vascular, Inc. is a global provider of devices for the treatment of peripheral vascular disease. We develop, manufacture, and market disposable & implantable vascular devices to address the n more...
SuturTek Incorporated | Address: 51 Middlesex St., N. Chelmsford, Massachusetts 01863, USA
www.suturtek.com | Send Inquiry | Phone: +1-(978)-251-8088
Products: Skin Closures, Suturing Kits & Removal Kits, Wound Closures, Skin Closures, Passive Closure Devices, Wound Closure System, Instruments for Minimally Invasive Surgery, ...
SuturTek Incorporated specializes in suturing/closure devices. Our product categories are minimally invasive surgery, fascia closure and sternal closure. Our Endo 360° minimally invasive suturing more...
www.suturtek.com | Send Inquiry | Phone: +1-(978)-251-8088
Products: Skin Closures, Suturing Kits & Removal Kits, Wound Closures, Skin Closures, Passive Closure Devices, Wound Closure System, Instruments for Minimally Invasive Surgery, ...
SuturTek Incorporated specializes in suturing/closure devices. Our product categories are minimally invasive surgery, fascia closure and sternal closure. Our Endo 360° minimally invasive suturing more...
Boston Scientific Corporation | Address: One Boston Scientific Place, Natick, Massachusetts 01760-1537, USA
www.bostonscientific.com | Phone: +1-(508)-650-8000
FDA Registration: 1828132
Products: Vaginal Retractors (FDA Code: HDL), Gastroenterologic Needle Holder (FDA Code: FHQ), Coronary Dilation Balloons, Compliant, Coronary Perfusion Balloons, Angiographic Catheter, Pigtail Diagnostic Catheters, El Gamal Angiographic Catheter, ...
Boston Scientific Corporation specializes in the development, manufacturing and marketing of medical devices. We also design and produce cardiovascular medical products. Our cardiovascular division co more...
www.bostonscientific.com | Phone: +1-(508)-650-8000
FDA Registration: 1828132
Products: Vaginal Retractors (FDA Code: HDL), Gastroenterologic Needle Holder (FDA Code: FHQ), Coronary Dilation Balloons, Compliant, Coronary Perfusion Balloons, Angiographic Catheter, Pigtail Diagnostic Catheters, El Gamal Angiographic Catheter, ...
Boston Scientific Corporation specializes in the development, manufacturing and marketing of medical devices. We also design and produce cardiovascular medical products. Our cardiovascular division co more...
Universal Medical Products, Inc. | Address: 1550 N. 20th Circle, Lincoln, Nebraska 68503, USA
www.u-m-p.com | Phone: +1-(800)-206-1045
Year Established: 1997 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Patient Monitoring Devices, Scalpel Blade (FDA Code: GES), Manual Stethoscope (FDA Code: LDE), Disposable Surgical Instrument Kit (FDA Code: KDD), Disposable Suture Needle (FDA Code: GAB), Reusable Suture Needle (FDA Code: GDL), ...
Universal Medical Products, Inc. develops, manufactures and markets restraint-free products. Our product list comprises of bed monitors, chair monitors, sentry bed & chair pads monitors, pull string m more...
www.u-m-p.com | Phone: +1-(800)-206-1045
Year Established: 1997 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Patient Monitoring Devices, Scalpel Blade (FDA Code: GES), Manual Stethoscope (FDA Code: LDE), Disposable Surgical Instrument Kit (FDA Code: KDD), Disposable Suture Needle (FDA Code: GAB), Reusable Suture Needle (FDA Code: GDL), ...
Universal Medical Products, Inc. develops, manufactures and markets restraint-free products. Our product list comprises of bed monitors, chair monitors, sentry bed & chair pads monitors, pull string m more...
Vienex USA Inc. | Address: 5190 Neil Road, Suite 430, Reno, Nevada 89502, USA
www.vienexusa.com | Send Inquiry | Phone: +1-(253)-793-2962
Products: Endometrial Biopsy Equipment, Vaginal Retractors (FDA Code: HDL), Gynaecological Instruments, Uterine Dilators, Used Surgical Instruments, Uterine Manipulators, Endocervical Curettes, ...
Vienex USA Inc. is a full-service medical product development company that specializes in the development of medical products and services related to women's health. We offer rapid product development more...
www.vienexusa.com | Send Inquiry | Phone: +1-(253)-793-2962
Products: Endometrial Biopsy Equipment, Vaginal Retractors (FDA Code: HDL), Gynaecological Instruments, Uterine Dilators, Used Surgical Instruments, Uterine Manipulators, Endocervical Curettes, ...
Vienex USA Inc. is a full-service medical product development company that specializes in the development of medical products and services related to women's health. We offer rapid product development more...
MYCO Medical | Address: 158 Towerview Court, Cary, North Carolina 27513, USA
www.mycomedical.com | Send Inquiry | Phone: +1-(800)-454-6926
FDA Registration: 1058382 Year Established: 1993 Employee Count: ~10 Quality: ISO 9001, CE Certified
Products: Anesthesia Equipment, Hypodermic Needles, Hypodermic Syringes, Scalpels, Sutures, Disposables, ...
MYCO Medical specializes in providing medical equipments. Our product line includes surgical blades & handles, safety scalpels, sutures, spinal and procedure needles. We also offer IV catheters, blood more...
www.mycomedical.com | Send Inquiry | Phone: +1-(800)-454-6926
FDA Registration: 1058382 Year Established: 1993 Employee Count: ~10 Quality: ISO 9001, CE Certified
Products: Anesthesia Equipment, Hypodermic Needles, Hypodermic Syringes, Scalpels, Sutures, Disposables, ...
MYCO Medical specializes in providing medical equipments. Our product line includes surgical blades & handles, safety scalpels, sutures, spinal and procedure needles. We also offer IV catheters, blood more...
Cincinnati Surgical Company, Inc. | Address: P.O. Box 42668, Cincinnati, Ohio 45242-0668, USA
www.cincinnatisurgical.com | Send Inquiry | Phone: +1-(800)-544-3100
FDA Registration: 1517254 Year Established: 1938 Annual Revenues: USD 1-5 Million Quality: ISO 9001, CE Certified
Products: Disposable Needles, General Medical Supplies, Suture Needles, Suture Cutters, Scalpel Handle (FDA Code: GDZ), Dissecting Scalpel Handle, ...
Cincinnati Surgical Company, Inc. provides surgical products such as specialty surgical blades & handles, suture needles, post mortem staplers, as well as industrial, utility, arts, crafts knives and more...
www.cincinnatisurgical.com | Send Inquiry | Phone: +1-(800)-544-3100
FDA Registration: 1517254 Year Established: 1938 Annual Revenues: USD 1-5 Million Quality: ISO 9001, CE Certified
Products: Disposable Needles, General Medical Supplies, Suture Needles, Suture Cutters, Scalpel Handle (FDA Code: GDZ), Dissecting Scalpel Handle, ...
Cincinnati Surgical Company, Inc. provides surgical products such as specialty surgical blades & handles, suture needles, post mortem staplers, as well as industrial, utility, arts, crafts knives and more...
R-Med, Inc. | Address: P.O. Box 167636, Oregon, Ohio 43616-7636, USA
rmed.com | Send Inquiry | Phone: +1-(419)-693-7481/800-355-7633
FDA Registration: 1529233
Products: Autoclaves, Forceps (FDA Code: HTD), Scissors, Needles, Clips, Arthroscopy Instruments, ...
R-Med,Inc. specializes in providing surgical instruments. Our products include Riza-Ribe® needle, R-Med® plug-10mm disposable, R-Med® mini-retractor, veres needles, dismountable trocar wit more...
rmed.com | Send Inquiry | Phone: +1-(419)-693-7481/800-355-7633
FDA Registration: 1529233
Products: Autoclaves, Forceps (FDA Code: HTD), Scissors, Needles, Clips, Arthroscopy Instruments, ...
R-Med,Inc. specializes in providing surgical instruments. Our products include Riza-Ribe® needle, R-Med® plug-10mm disposable, R-Med® mini-retractor, veres needles, dismountable trocar wit more...
Xodus Medical, Inc. | Address: Westmoreland Business & Research Park, 702 Prominence Drive, New Kensington, Pennsylvania 15068, USA
www.xodusmedical.com | Send Inquiry | Phone: +1-(724)-337-5500, 800-963-8776
FDA Registration: 2530138 Year Established: 1994 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO 9000, CE Certified
Products: Face Masks, Bowls & Basins, Sponges, Adhesive Bandages (FDA Code: KGX), Surgical Trays (FDA Code: LRP), Suction Tubing, ...
Xodus Medical, Inc. specializes in offering medical safety products. We offer a wide range of products including surgical EZ kits™, safety products, custom medication labels, electrosurgical, pa more...
www.xodusmedical.com | Send Inquiry | Phone: +1-(724)-337-5500, 800-963-8776
FDA Registration: 2530138 Year Established: 1994 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO 9000, CE Certified
Products: Face Masks, Bowls & Basins, Sponges, Adhesive Bandages (FDA Code: KGX), Surgical Trays (FDA Code: LRP), Suction Tubing, ...
Xodus Medical, Inc. specializes in offering medical safety products. We offer a wide range of products including surgical EZ kits™, safety products, custom medication labels, electrosurgical, pa more...
Bausch & Lomb Inc. | Address: 8507 Pelham Rd., Greenville, South Carolina 29615-9598, USA
Phone: +1-(585)-338-6000
FDA Registration: 1032500
Products: Daily Wear Soft Contact Lenses (FDA Code: LPL), Extended Wear Soft Contact Lenses (FDA Code: LPM), Lacrimal Probes (FDA Code: HNL), Powered Surgical Laser Instrument (FDA Code: GEX), Contact Lens (FDA Code: HQD), Surgical Drapes & Packs (FDA Code: KKX), ...
Bausch & Lomb Inc. specializes in offering contact lens and contact lens care products. more...
Phone: +1-(585)-338-6000
FDA Registration: 1032500
Products: Daily Wear Soft Contact Lenses (FDA Code: LPL), Extended Wear Soft Contact Lenses (FDA Code: LPM), Lacrimal Probes (FDA Code: HNL), Powered Surgical Laser Instrument (FDA Code: GEX), Contact Lens (FDA Code: HQD), Surgical Drapes & Packs (FDA Code: KKX), ...
Bausch & Lomb Inc. specializes in offering contact lens and contact lens care products. more...
Arthrocare Corporation | Address: 7500 Rialto Boulevard, Building Two, Suite 100, Austin, Texas 78735, USA
www.arthrocare.com | Send Inquiry | Phone: +1-(512)-391-3900
FDA Registration: 3012358417 Year Established: 1993 Annual Revenues: < USD 1 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Drills, Vertebroplasty, Bone Cement (FDA Code: LOD), Delivery Systems, Ear & Hearing Protection, Goggles & Protective Eyewear, ...
Arthrocare Corporation designs surgical instruments that improve patient outcomes by using our internationally patented Coblation® technology. Our technology precisely dissolves target tissue and more...
www.arthrocare.com | Send Inquiry | Phone: +1-(512)-391-3900
FDA Registration: 3012358417 Year Established: 1993 Annual Revenues: < USD 1 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Drills, Vertebroplasty, Bone Cement (FDA Code: LOD), Delivery Systems, Ear & Hearing Protection, Goggles & Protective Eyewear, ...
Arthrocare Corporation designs surgical instruments that improve patient outcomes by using our internationally patented Coblation® technology. Our technology precisely dissolves target tissue and more...
Suturas Medical Llc | Address: 508 Jefferson Street, Eagle Pass, Texas 78852, USA
www.suturasmedical.com | Phone: +1-(866)-822 6550
Quality: ISO 9001 Certified
Products: Absorbable Sutures (FDA Code: GAK), Absorbable Surgical Sutures, Surgical Non Absorbable Sutures, Surgical Sutures, Proline Sutures, Polysorb Sutures, ...
Suturas Medical Llc is a surgical suture company. We offer absorbable & non-absorbable suture materials. Our range of needle/suture combinations provide products for every application. Our products in more...
www.suturasmedical.com | Phone: +1-(866)-822 6550
Quality: ISO 9001 Certified
Products: Absorbable Sutures (FDA Code: GAK), Absorbable Surgical Sutures, Surgical Non Absorbable Sutures, Surgical Sutures, Proline Sutures, Polysorb Sutures, ...
Suturas Medical Llc is a surgical suture company. We offer absorbable & non-absorbable suture materials. Our range of needle/suture combinations provide products for every application. Our products in more...
Medicinelodge, Inc. | Address: 180 South 600 West, Nibley, Utah 84321, USA
www.medicinelodge.com | Phone: +1-(435)-7537675
FDA Registration: 3004086872
Products: Disposable Suture Needle (FDA Code: GAB), General Surgical Manual Instrument (FDA Code: MDM), Implantable Clip (FDA Code: FZP), ...
Medicinelodge, Inc. provides implantable clips. more...
www.medicinelodge.com | Phone: +1-(435)-7537675
FDA Registration: 3004086872
Products: Disposable Suture Needle (FDA Code: GAB), General Surgical Manual Instrument (FDA Code: MDM), Implantable Clip (FDA Code: FZP), ...
Medicinelodge, Inc. provides implantable clips. more...
Hospital & Homecare Imp. & Exp. Co., Ltd. | Address: Room 608-611, No.5 Zhongtai Int. Plaza, No.311 Middle of Jiangdong Rd, Central Business Dist, Nanjing, Jiangsu, China 
www.aline-medical.com | Send Inquiry | Phone: +86-(25)-84573232
FDA Registration: 3006897996
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Urine Collection Leg Bags (FDA Code: FAQ), Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), ...
Hospital & Homecare Imp. & Exp. Co., Ltd. is mainly engaged in medical product development, covering thousands of products within the medical field. We provide Surgical & Optical Instruments, Laborato more...
www.aline-medical.com | Send Inquiry | Phone: +86-(25)-84573232
FDA Registration: 3006897996
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Urine Collection Leg Bags (FDA Code: FAQ), Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), ...
Hospital & Homecare Imp. & Exp. Co., Ltd. is mainly engaged in medical product development, covering thousands of products within the medical field. We provide Surgical & Optical Instruments, Laborato more...
Tyco Healthcare UK Ltd. | Address: Fareham Rd., Gosport, Hants, United Kingdom 
www.tycohealthcare.co.uk | Send Inquiry | Phone: +44-(1329)-224114
Products: Non-Absorbable Sutures (FDA Code: GAO), Surgical Staplers, Circular Staplers, Surgical Staplers, Titanium Staples, Surgical Staplers, Stainless Steel Staples, Surgical Retractor Systems (FDA Code: GAD), Ophthalmology, Surgical Instrument Trays, ...
Tyco Healthcare UK Ltd. is a manufacturer and distributor of medical devices. Our products include disposable medical supplies, monitoring equipment, medical instruments and bulk analgesic pharmaceuti more...
www.tycohealthcare.co.uk | Send Inquiry | Phone: +44-(1329)-224114
Products: Non-Absorbable Sutures (FDA Code: GAO), Surgical Staplers, Circular Staplers, Surgical Staplers, Titanium Staples, Surgical Staplers, Stainless Steel Staples, Surgical Retractor Systems (FDA Code: GAD), Ophthalmology, Surgical Instrument Trays, ...
Tyco Healthcare UK Ltd. is a manufacturer and distributor of medical devices. Our products include disposable medical supplies, monitoring equipment, medical instruments and bulk analgesic pharmaceuti more...
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FDA Code / Regulation: GAB / 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.
