Surgical Needle Guide Suppliers
Limit companies to: Worldwide USA
Allez Medical Applications, Inc. | Address: 2141 S. Standard Avenue, Santa Ana, California 92707, USA 
www.allezmedical.com | Send Inquiry | Phone: +1-(714)-641-2098
Products: Suture Needles, Suture Instruments, Laparoscopic Suture Passing Instrument, Surgical Needle Guide (FDA Code: GDF), Probes (FDA Code: HXB), Surgical Fascia Closure Systems, ...
Allez Medical Applications, Inc. is a manufacturer of surgical products for general laparoscopy, gynecology, orthopedics, urology and bariatric surgery. We develop, manufacture and distribute new, inn more...
www.allezmedical.com | Send Inquiry | Phone: +1-(714)-641-2098
Products: Suture Needles, Suture Instruments, Laparoscopic Suture Passing Instrument, Surgical Needle Guide (FDA Code: GDF), Probes (FDA Code: HXB), Surgical Fascia Closure Systems, ...
Allez Medical Applications, Inc. is a manufacturer of surgical products for general laparoscopy, gynecology, orthopedics, urology and bariatric surgery. We develop, manufacture and distribute new, inn more...
TMX Engineering & Manufacturing, Inc. | Address: 2141 S. Standard Ave., Santa Ana, California 92707, USA
www.tmxengineering.com | Send Inquiry | Phone: +1-(714)-641-5884
Products: Surgical Needle Guide (FDA Code: GDF), ...
TMX Engineering & Manufacturing, Inc. is involved in the manufacturing & precision machining of metal and plastics, short & long runs for medical and general commercial companies. We are an Iso 9001 a more...
www.tmxengineering.com | Send Inquiry | Phone: +1-(714)-641-5884
Products: Surgical Needle Guide (FDA Code: GDF), ...
TMX Engineering & Manufacturing, Inc. is involved in the manufacturing & precision machining of metal and plastics, short & long runs for medical and general commercial companies. We are an Iso 9001 a more...
Crosstrees Medical, Inc. | Address: 4735 Walnut Street, Suite E, Boulder, Colorado 80301, USA
xtreesmed.com | Send Inquiry | Phone: +1-(886)-442-2328
Products: Drill Bit (FDA Code: HTW), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), Surgical Needle Guide (FDA Code: GDF), Percutaneous Biopsy Device (FDA Code: MJG), Impactor (FDA Code: HWA), Orthopedic Manual Surgical Instrument (FDA Code: LXH), ...
Crosstrees Medical, Inc. specializes in crosstrees system for vertebroplasty and kyphoplasty in the treatment of compression fractures. It is designed to control bone cement delivery and decrease the more...
xtreesmed.com | Send Inquiry | Phone: +1-(886)-442-2328
Products: Drill Bit (FDA Code: HTW), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), Surgical Needle Guide (FDA Code: GDF), Percutaneous Biopsy Device (FDA Code: MJG), Impactor (FDA Code: HWA), Orthopedic Manual Surgical Instrument (FDA Code: LXH), ...
Crosstrees Medical, Inc. specializes in crosstrees system for vertebroplasty and kyphoplasty in the treatment of compression fractures. It is designed to control bone cement delivery and decrease the more...
Worldwide Medical Technologies | Address: 115 Hurley Road, Bldg. 3, Oxford, Connecticut 6478, USA
www.wwmedtech.com | Send Inquiry | Phone: +1-(203)-262-4190, 877-783-5463
FDA Registration: 1225114 Year Established: 1996 Annual Revenues: USD 5-10 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Biopsy Instruments (FDA Code: KNW), Enteral Irrigation Kit w/Piston Syringe, Hemorrhoidal Ligator (FDA Code: FHN), Piston Syringe (FDA Code: FMF), Biopsy Instruments (FDA Code: KNW), Anesthesia Conduction Kit (FDA Code: CAZ), ...
Worldwide Medical Technologies is a provider of medical instruments. Our medical instruments include prostate seeding systems, core-lock bone marrow needles, cutting biopsy needles, breast lesion loca more...
www.wwmedtech.com | Send Inquiry | Phone: +1-(203)-262-4190, 877-783-5463
FDA Registration: 1225114 Year Established: 1996 Annual Revenues: USD 5-10 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Biopsy Instruments (FDA Code: KNW), Enteral Irrigation Kit w/Piston Syringe, Hemorrhoidal Ligator (FDA Code: FHN), Piston Syringe (FDA Code: FMF), Biopsy Instruments (FDA Code: KNW), Anesthesia Conduction Kit (FDA Code: CAZ), ...
Worldwide Medical Technologies is a provider of medical instruments. Our medical instruments include prostate seeding systems, core-lock bone marrow needles, cutting biopsy needles, breast lesion loca 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...
Invivo | Address: 12501 Research Parkway, Orlando, Florida 32826, USA
www.invivocorp.com | Send Inquiry | Phone: +1-(407)-275-3220, 800-331-3220
FDA Registration: 1056069 Year Established: 1987 Annual Revenues: USD 10-25 Million Quality: ISO 9001, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Monopolar Electrode Cables, Electrode Cables (FDA Code: IKD), Electrosurgery, General Medical Supplies, Pulse Oximeters, ...
Invivo specializes in MRI monitoring, which provides accurate vital signs for improved patient safety. Our 4500 MRI pulse oximeter uses advanced fiberoptic technology to provide accurate SpO2 readings more...
www.invivocorp.com | Send Inquiry | Phone: +1-(407)-275-3220, 800-331-3220
FDA Registration: 1056069 Year Established: 1987 Annual Revenues: USD 10-25 Million Quality: ISO 9001, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Monopolar Electrode Cables, Electrode Cables (FDA Code: IKD), Electrosurgery, General Medical Supplies, Pulse Oximeters, ...
Invivo specializes in MRI monitoring, which provides accurate vital signs for improved patient safety. Our 4500 MRI pulse oximeter uses advanced fiberoptic technology to provide accurate SpO2 readings more...
C. R. Bard, Inc., Bard Medical Div. | Address: 8195 Industrial Blvd., Covington, Georgia 30209, USA
www.bardmedical.com | Send Inquiry | Phone: +1-(770)-784-6100, 800-526-4455
FDA Registration: 3006082230 Quality: ISO 9001 Certified
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Catheter Introducers (FDA Code: DYB), Arthroscopes (FDA Code: HRX), Electrode Cables (FDA Code: IKD), Urethral Catheters (FDA Code: GBM), Urine Collection Leg Bags (FDA Code: FAQ), ...
C. R. Bard, Inc., Bard Medical Div. provides products and services that meet the needs of healthcare providers & patients. We specialize in disease state management offering the industry's comprehensi more...
www.bardmedical.com | Send Inquiry | Phone: +1-(770)-784-6100, 800-526-4455
FDA Registration: 3006082230 Quality: ISO 9001 Certified
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Catheter Introducers (FDA Code: DYB), Arthroscopes (FDA Code: HRX), Electrode Cables (FDA Code: IKD), Urethral Catheters (FDA Code: GBM), Urine Collection Leg Bags (FDA Code: FAQ), ...
C. R. Bard, Inc., Bard Medical Div. provides products and services that meet the needs of healthcare providers & patients. We specialize in disease state management offering the industry's comprehensi 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...
Promex Technologies, LLC | Address: 3049 Hudson St., Franklin, Indiana 46131, USA
www.promextech.com | Send Inquiry | Phone: +1-(317)-736-0128,800-755-1671
Products: Catheter Introducers (FDA Code: DYB), Prostate Biopsy Needles, Biopsy Instruments (FDA Code: KNW), Soft Tissue Biopsy Needles, Disposable Biopsy Needle, Liver Biopsy kit, ...
Promex Technologies, LLC develops innovative and proprietary technologies that are applied to biopsy needles & other minimally invasive tissue cutting & removal systems. We offer a complete line of bi more...
www.promextech.com | Send Inquiry | Phone: +1-(317)-736-0128,800-755-1671
Products: Catheter Introducers (FDA Code: DYB), Prostate Biopsy Needles, Biopsy Instruments (FDA Code: KNW), Soft Tissue Biopsy Needles, Disposable Biopsy Needle, Liver Biopsy kit, ...
Promex Technologies, LLC develops innovative and proprietary technologies that are applied to biopsy needles & other minimally invasive tissue cutting & removal systems. We offer a complete line of bi 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...
Symmetry Medical Inc. | Address: New Bedford Industrial Park, New Bedford, Massachusetts 02745, USA
www.symmetrymedical.com | Phone: +1-(508)-998-4493
Products: Vaginal Retractors (FDA Code: HDL), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Instruments, Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
Symmetry Medical Inc. manufactures implants, instruments and cases to orthopedic devices. We offer cases and trays that made of metal, plastic or hybrid. We provide forged, cast, machined and finished more...
www.symmetrymedical.com | Phone: +1-(508)-998-4493
Products: Vaginal Retractors (FDA Code: HDL), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Instruments, Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
Symmetry Medical Inc. manufactures implants, instruments and cases to orthopedic devices. We offer cases and trays that made of metal, plastic or hybrid. We provide forged, cast, machined and finished more...
Gallini U.S. | Address: 3574 Roger B. Chaffee SE, Grand Rapids, Michigan 49548, USA
www.gallinimedical.com | Phone: +1-(616)-241-9987, 888-361-6941
FDA Registration: 1125067
Products: Catheters, Balloon Inflation Devices, Catheter Accessories (FDA Code: KGZ), Biopsy Instruments (FDA Code: KNW), Drainage Bag, Ureteral Catheter, ...
Gallini U.S. specializes in the development and manufacture of single patient use biopsy needles and catheters for hospital use. We offer a wide variety of disposable and specialty products within rad more...
www.gallinimedical.com | Phone: +1-(616)-241-9987, 888-361-6941
FDA Registration: 1125067
Products: Catheters, Balloon Inflation Devices, Catheter Accessories (FDA Code: KGZ), Biopsy Instruments (FDA Code: KNW), Drainage Bag, Ureteral Catheter, ...
Gallini U.S. specializes in the development and manufacture of single patient use biopsy needles and catheters for hospital use. We offer a wide variety of disposable and specialty products within rad more...
INRAD | Address: 4375 Donker Court S.E., Kentwood, Michigan 49512, USA
www.inradinc.com | Send Inquiry | Phone: +1-(616)-301-7800, 800-558-4647
FDA Registration: 1835568 Year Established: 1981 Annual Revenues: USD 5-10 Million Employee Count: ~10 Quality: ISO 9001, CE Certified
Products: Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Catheter Introducers, MULLINS, Biopsy Instruments (FDA Code: KNW), Aspiration Needles, Implantable Venous Access Catheter Introducer Kits, ...
Inrad is a developer, manufacturer and distributor of medical devices serving the radiology & biopsy markets. We help to reduce the uncertainty in diagnosis by creating devices that offer more precisi more...
www.inradinc.com | Send Inquiry | Phone: +1-(616)-301-7800, 800-558-4647
FDA Registration: 1835568 Year Established: 1981 Annual Revenues: USD 5-10 Million Employee Count: ~10 Quality: ISO 9001, CE Certified
Products: Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Catheter Introducers, MULLINS, Biopsy Instruments (FDA Code: KNW), Aspiration Needles, Implantable Venous Access Catheter Introducer Kits, ...
Inrad is a developer, manufacturer and distributor of medical devices serving the radiology & biopsy markets. We help to reduce the uncertainty in diagnosis by creating devices that offer more precisi more...
Rhein Mfg., Inc. | Address: 2269 Grissom Dr., St. Louis, Missouri 63146, USA
Phone: +1-(314)-997-1775
FDA Registration: 1932214
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Lacrimal Dilator (FDA Code: HNW), Bone Clamp (FDA Code: HXD), Ophthalmic Caliper (FDA Code: HOE), ...
Rhein Mfg., Inc. specializes in general surgical instruments, ophthalmic surgical forceps and endoscopic surgical instruments. more...
Phone: +1-(314)-997-1775
FDA Registration: 1932214
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Lacrimal Dilator (FDA Code: HNW), Bone Clamp (FDA Code: HXD), Ophthalmic Caliper (FDA Code: HOE), ...
Rhein Mfg., Inc. specializes in general surgical instruments, ophthalmic surgical forceps and endoscopic surgical instruments. more...
Arjon Industries | Address: 7550 N. Broadway, St. Louis, Missouri 63147, USA
www.arjonindustries.com | Send Inquiry | Phone: +1-(314)-383-2879
Products: Adhesive Bandages (FDA Code: KGX), Surgical Caps (FDA Code: FYF), Non Dental Irrigating Syringe (FDA Code: KYZ), Blood Collection Lancet (FDA Code: FMK), Isotonic Solution (FDA Code: JCE), Conductive Shoe and Shoe Cover (FDA Code: BWP), ...
Arjon Industries deals with Kitpackers systems. Our kits are customizable, pursuant to end-user specifications, and samples are readily available for clinical evaluations. Our products include cathete more...
www.arjonindustries.com | Send Inquiry | Phone: +1-(314)-383-2879
Products: Adhesive Bandages (FDA Code: KGX), Surgical Caps (FDA Code: FYF), Non Dental Irrigating Syringe (FDA Code: KYZ), Blood Collection Lancet (FDA Code: FMK), Isotonic Solution (FDA Code: JCE), Conductive Shoe and Shoe Cover (FDA Code: BWP), ...
Arjon Industries deals with Kitpackers systems. Our kits are customizable, pursuant to end-user specifications, and samples are readily available for clinical evaluations. Our products include cathete more...
Angiodynamics, Inc. | Address: 603 Queensbury Ave, Queensbury, New York 12804, USA
www.angiodynamics.com | Send Inquiry | Phone: +1-(518)-798-1215, 800-772-6446
FDA Registration: 1056436 Year Established: 1990 Annual Revenues: USD 25-50 Million Employee Count: ~150 Quality: ISO 9001, CE Certified
Products: El Gamal Angiographic Catheter, Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Powered Surgical Laser Instrument (FDA Code: GEX), Central Venous Catheters, Angiographic Catheter, Angled Pigtail, ...
Angiodynamics, Inc. provides medical devices for radiologists, surgeons, and other physicians. We offer medical devices for the minimally invasive diagnosis and treatment of cancer and peripheral vasc more...
www.angiodynamics.com | Send Inquiry | Phone: +1-(518)-798-1215, 800-772-6446
FDA Registration: 1056436 Year Established: 1990 Annual Revenues: USD 25-50 Million Employee Count: ~150 Quality: ISO 9001, CE Certified
Products: El Gamal Angiographic Catheter, Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Powered Surgical Laser Instrument (FDA Code: GEX), Central Venous Catheters, Angiographic Catheter, Angled Pigtail, ...
Angiodynamics, Inc. provides medical devices for radiologists, surgeons, and other physicians. We offer medical devices for the minimally invasive diagnosis and treatment of cancer and peripheral vasc more...
Havels Inc | Address: 3726 Lonsdale Street, Cincinnati, Ohio 45227, USA
www.havels.com | Send Inquiry | Phone: +001-(800)-638-4770
FDA Registration: 1526069 Year Established: 1981 Annual Revenues: USD 5-10 Million Employee Count: ~20 Quality: CE Certified
Products: Scalpels, Mini Blades, Absorbable Suture Anchors, Absorbable Sutures (FDA Code: GAK), Surgical Blades, Surgical Handles, ...
Havels Inc supplies products for a variety of industries including medical, dental, industrial cutting and graphic arts products. Our quality dental & dermatology sutures, are available in silk, gut, more...
www.havels.com | Send Inquiry | Phone: +001-(800)-638-4770
FDA Registration: 1526069 Year Established: 1981 Annual Revenues: USD 5-10 Million Employee Count: ~20 Quality: CE Certified
Products: Scalpels, Mini Blades, Absorbable Suture Anchors, Absorbable Sutures (FDA Code: GAK), Surgical Blades, Surgical Handles, ...
Havels Inc supplies products for a variety of industries including medical, dental, industrial cutting and graphic arts products. Our quality dental & dermatology sutures, are available in silk, gut, more...
Health Care Logistics | Address: PO Box 25, Circleville, Ohio 43113-0025, USA
www.hcl-intl.com | Send Inquiry | Phone: +1-(800)-848-1633
FDA Registration: 1530671 Year Established: 1978 Employee Count: ~120
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Capillary Blood Collection Tubes (FDA Code: GIO), Urine Collection Leg Bags (FDA Code: FAQ), Cabinets, IV Catheters & Infusion Sets, ...
Health Care Logistics supplies emergency products, pharmacy products, infection control products, key cabinets & tablet crushers. Our extensive line of daily aids include ideas such as medication orga more...
www.hcl-intl.com | Send Inquiry | Phone: +1-(800)-848-1633
FDA Registration: 1530671 Year Established: 1978 Employee Count: ~120
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Capillary Blood Collection Tubes (FDA Code: GIO), Urine Collection Leg Bags (FDA Code: FAQ), Cabinets, IV Catheters & Infusion Sets, ...
Health Care Logistics supplies emergency products, pharmacy products, infection control products, key cabinets & tablet crushers. Our extensive line of daily aids include ideas such as medication orga more...
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FDA Code / Regulation: GDF / 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.
