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), Arthroscopic Tools, ...
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), Arthroscopic Tools, ...
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), Percutaneous Biopsy Device (FDA Code: MJG), Impactor (FDA Code: HWA), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Vertebroplasty Spinal Channeling Instrument (FDA Code: OCJ), ...
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), Percutaneous Biopsy Device (FDA Code: MJG), Impactor (FDA Code: HWA), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Vertebroplasty Spinal Channeling Instrument (FDA Code: OCJ), ...
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), Anesthesia Conduction Kit (FDA Code: CAZ), Cardiovascular Trocar (FDA Code: DRC), Disposable Aspiration and Injection Needle (FDA Code: GAA), Bone Marrow Collection/Transfusion Kit (FDA Code: LWE), Biopsy Needle Kit (FDA Code: FCG), ...
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), Anesthesia Conduction Kit (FDA Code: CAZ), Cardiovascular Trocar (FDA Code: DRC), Disposable Aspiration and Injection Needle (FDA Code: GAA), Bone Marrow Collection/Transfusion Kit (FDA Code: LWE), Biopsy Needle Kit (FDA Code: FCG), ...
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: Basic Plastic Surgery Tray, Blepharoplasty Tray, Craniofacial Surgery Tray, Biopsy Trays, Bone Graft Replacement, Angle Blade Plate Instrument, ...
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: Basic Plastic Surgery Tray, Blepharoplasty Tray, Craniofacial Surgery Tray, Biopsy Trays, Bone Graft Replacement, Angle Blade Plate Instrument, ...
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: Electrosurgery, General Medical Supplies, Pulse Oximeters, Conmed Electrosurgery, Electrodes and Other Components, Gold Cup Electrodes, Blood Pressure Cuff Barriers, ...
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: Electrosurgery, General Medical Supplies, Pulse Oximeters, Conmed Electrosurgery, Electrodes and Other Components, Gold Cup Electrodes, Blood Pressure Cuff Barriers, ...
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: Arthroscopes (FDA Code: HRX), Adhesive Bandages (FDA Code: KGX), Autotransfusion Apparatus (FDA Code: CAC), Active Electrosurgical Electrode (FDA Code: FAS), AV Shunt Accessories (FDA Code: KNZ), Anti-Infective Latex Foley Catheters, ...
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: Arthroscopes (FDA Code: HRX), Adhesive Bandages (FDA Code: KGX), Autotransfusion Apparatus (FDA Code: CAC), Active Electrosurgical Electrode (FDA Code: FAS), AV Shunt Accessories (FDA Code: KNZ), Anti-Infective Latex Foley Catheters, ...
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: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
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: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
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: Saws (FDA Code: HSO), General & Plastic Saw Surgical Blade (FDA Code: GFA), Drill Handpiece (Brace) (FDA Code: HBD), Surgical Knife (FDA Code: EMF), Neurosurgical Suture Needle (FDA Code: HAS), Gynecological Cerclage Needle (FDA Code: HDH), ...
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: Saws (FDA Code: HSO), General & Plastic Saw Surgical Blade (FDA Code: GFA), Drill Handpiece (Brace) (FDA Code: HBD), Surgical Knife (FDA Code: EMF), Neurosurgical Suture Needle (FDA Code: HAS), Gynecological Cerclage Needle (FDA Code: HDH), ...
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: Prostate Biopsy Needles, Soft Tissue Biopsy Needles, Disposable Biopsy Needle, Liver Biopsy kit, Biopsy Kit, Biopsy Needle Kit (FDA Code: FCG), ...
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: Prostate Biopsy Needles, Soft Tissue Biopsy Needles, Disposable Biopsy Needle, Liver Biopsy kit, Biopsy Kit, Biopsy Needle Kit (FDA Code: FCG), ...
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: Active Fixation Steroid Eluting, Angiographic Catheter, Angled Pigtail, Angiographic Catheter Amplatz Left 1.0, Ablation Catheter, Alligator Jaw-step Biopsy Forceps, 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: Active Fixation Steroid Eluting, Angiographic Catheter, Angled Pigtail, Angiographic Catheter Amplatz Left 1.0, Ablation Catheter, Alligator Jaw-step Biopsy Forceps, 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: Calipers, Flexible Osteotome System, Bone Tamp, Orthopedic Caliper, Reamer (FDA Code: HTO), Screw Removal Systems, ...
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: Calipers, Flexible Osteotome System, Bone Tamp, Orthopedic Caliper, Reamer (FDA Code: HTO), Screw Removal Systems, ...
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: Catheter Accessories (FDA Code: KGZ), Biopsy Instruments (FDA Code: KNW), Biopsy Instruments (FDA Code: KNW), Catheter Needle (FDA Code: GCB), Surgical Needle Guide (FDA Code: GDF), Biopsy Needle Kit (FDA Code: FCG), ...
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: Catheter Accessories (FDA Code: KGZ), Biopsy Instruments (FDA Code: KNW), Biopsy Instruments (FDA Code: KNW), Catheter Needle (FDA Code: GCB), Surgical Needle Guide (FDA Code: GDF), Biopsy Needle Kit (FDA Code: FCG), ...
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, Biopsy Instruments (FDA Code: KNW), Aspiration Needles, Biopsy Instruments (FDA Code: KNW), Biopsy Needle Kit (FDA Code: FCG), ...
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, Biopsy Instruments (FDA Code: KNW), Aspiration Needles, Biopsy Instruments (FDA Code: KNW), Biopsy Needle Kit (FDA Code: FCG), ...
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), Ophthalmic Forceps (FDA Code: HNR), Disposable Aspiration and Injection Needle (FDA Code: GAA), General & Plastic Surgery Forceps (FDA Code: GEN), General & Plastic Surgery Surgical Clamp (FDA Code: GDJ), General Surgical Scissors (FDA Code: LRW), ...
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), Ophthalmic Forceps (FDA Code: HNR), Disposable Aspiration and Injection Needle (FDA Code: GAA), General & Plastic Surgery Forceps (FDA Code: GEN), General & Plastic Surgery Surgical Clamp (FDA Code: GDJ), General Surgical Scissors (FDA Code: LRW), ...
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), Blood Collection Lancet (FDA Code: FMK), Conductive Shoe and Shoe Cover (FDA Code: BWP), Disposable Medical Bed (FDA Code: KME), Emesis Basin (FDA Code: FNY), Incontinence Protective Garment (FDA Code: EYQ), ...
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), Blood Collection Lancet (FDA Code: FMK), Conductive Shoe and Shoe Cover (FDA Code: BWP), Disposable Medical Bed (FDA Code: KME), Emesis Basin (FDA Code: FNY), Incontinence Protective Garment (FDA Code: EYQ), ...
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: Angiographic Catheter, Angled Pigtail, Angiographic Catheter Amplatz Left 1.0, Angiographic Catheter, El Gamal Sones, Angiographic Catheter, El Gamal Multipurpose, Anesthetic Infusion Pump (FDA Code: FRN), Angiographic Catheter, ...
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: Angiographic Catheter, Angled Pigtail, Angiographic Catheter Amplatz Left 1.0, Angiographic Catheter, El Gamal Sones, Angiographic Catheter, El Gamal Multipurpose, Anesthetic Infusion Pump (FDA Code: FRN), Angiographic Catheter, ...
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: Surgical Blades, Surgical Handles, General Medical Supplies, General Hypodermic Supplies, Procedure Kits & Packs, Reusable Needles, ...
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: Surgical Blades, Surgical Handles, General Medical Supplies, General Hypodermic Supplies, Procedure Kits & Packs, Reusable Needles, ...
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: Adhesive Bandages (FDA Code: KGX), Acid and Corrosive Chemical Storage, Polypropylene Cabinets, Adhesive Elastic Bandage Tape, Angular Ear Curette, Anesthesiology Oropharyngeal Airway (FDA Code: CAE), Anesthesia Table and Tray Cabinet (FDA Code: BRY), ...
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: Adhesive Bandages (FDA Code: KGX), Acid and Corrosive Chemical Storage, Polypropylene Cabinets, Adhesive Elastic Bandage Tape, Angular Ear Curette, Anesthesiology Oropharyngeal Airway (FDA Code: CAE), Anesthesia Table and Tray Cabinet (FDA Code: BRY), ...
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.
