Percutaneous Biopsy Device Suppliers
Limit companies to: Worldwide USA
Angiotech Pharmaceuticals, Inc. | Address: 1618 Station Street, Vancouver V6A 1B6, USA 
www.angiotech.com | Send Inquiry | Phone: +1-(604)-221-7676
Year Established: 2003 Annual Revenues: USD 25-50 Million Employee Count: ~150 Quality: ISO 9001, CE Certified
Products: Contract Manufacturers, Needles, General Hypodermic Supplies, Diagnostic Kits, Medical Ultrasound Devices, Biopsy Instruments (FDA Code: KNW), ...
Angiotech Pharmaceuticals, Inc. is a global specialty pharmaceutical and medical device company that discovers, develops, & markets innovative technologies & medical products primarily for local disea more...
www.angiotech.com | Send Inquiry | Phone: +1-(604)-221-7676
Year Established: 2003 Annual Revenues: USD 25-50 Million Employee Count: ~150 Quality: ISO 9001, CE Certified
Products: Contract Manufacturers, Needles, General Hypodermic Supplies, Diagnostic Kits, Medical Ultrasound Devices, Biopsy Instruments (FDA Code: KNW), ...
Angiotech Pharmaceuticals, Inc. is a global specialty pharmaceutical and medical device company that discovers, develops, & markets innovative technologies & medical products primarily for local disea more...
Cooper Surgical, Inc. | Address: 95 Corporate Drive, Trumbul, Connecticut 06611, USA
www.coopersurgical.com | Send Inquiry | Phone: +001-(203)-601-5200
FDA Registration: 1216677 Year Established: 1990 Annual Revenues: USD 100-500 Million Employee Count: ~430 Quality: ISO 9001, CE Certified
Products: Colposcopes, Disposable Examination Gloves, Vaginal Retractors (FDA Code: HDL), Probes (FDA Code: HXB), Incubators, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Cooper Surgical, Inc. provides medical devices and procedure solutions that improve health care delivery to women regardless of the clinical setting. Our product categories are obstetrics, family plan more...
www.coopersurgical.com | Send Inquiry | Phone: +001-(203)-601-5200
FDA Registration: 1216677 Year Established: 1990 Annual Revenues: USD 100-500 Million Employee Count: ~430 Quality: ISO 9001, CE Certified
Products: Colposcopes, Disposable Examination Gloves, Vaginal Retractors (FDA Code: HDL), Probes (FDA Code: HXB), Incubators, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Cooper Surgical, Inc. provides medical devices and procedure solutions that improve health care delivery to women regardless of the clinical setting. Our product categories are obstetrics, family plan more...
Medtronic Xomed Surgical Products, Inc | Address: 6743 Southpoint Drive North, Jacksonville, Florida 32216-0980, USA
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Sinus Trochars and Cannulae, Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Navigation Interface/Display, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Sinus Trochars and Cannulae, Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Navigation Interface/Display, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
Depuy Spine, Inc. | Address: 325 Paramount Drive, Raynham, Massachusetts 02767, USA
www.depuyacromed.com | Send Inquiry | Phone: +1-(508)-880-8100
FDA Registration: 1526439 Year Established: 1895
Products: Cables, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Skull Clamps and Pins, Synthetic Spacers, Occipital Fixation Systems, ...
Depuy Spine, Inc. designs, manufactures and sells orthopaedic devices & supplies. Our Devex™ System is indicated for use in the thoracolumbar spine to replace a diseased vertebral body resected more...
www.depuyacromed.com | Send Inquiry | Phone: +1-(508)-880-8100
FDA Registration: 1526439 Year Established: 1895
Products: Cables, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Skull Clamps and Pins, Synthetic Spacers, Occipital Fixation Systems, ...
Depuy Spine, Inc. designs, manufactures and sells orthopaedic devices & supplies. Our Devex™ System is indicated for use in the thoracolumbar spine to replace a diseased vertebral body resected more...
Aesculap Inc. | Address: 3773 Corporate Parkway, Center Valley, Pennsylvania 18034, USA
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Vaginal Retractors (FDA Code: HDL), Curettes, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Vaginal Retractors (FDA Code: HDL), Curettes, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
Orthovita | Address: 77 Great Valley Parkway, Malvern, Pennsylvania 19355, USA
www.orthovita.com | Send Inquiry | Phone: +1-(610)-640-1775
FDA Registration: 2530131 Year Established: 1992
Products: Hydroxyapatite Orbital Implants, Synthetic Spacers, Hydroxyapatite, Biopsy Instruments (FDA Code: KNW), Artificial Hydroxyapatite Orbital Implant, Bio-Eyes Hydroxyapatite Orbital Implant, ...
Orthovita is a biomaterials company with proprietary technologies applied to the development of biostructures. We focus on novel products for use in spine surgery and in the repair of osteoporotic fra more...
www.orthovita.com | Send Inquiry | Phone: +1-(610)-640-1775
FDA Registration: 2530131 Year Established: 1992
Products: Hydroxyapatite Orbital Implants, Synthetic Spacers, Hydroxyapatite, Biopsy Instruments (FDA Code: KNW), Artificial Hydroxyapatite Orbital Implant, Bio-Eyes Hydroxyapatite Orbital Implant, ...
Orthovita is a biomaterials company with proprietary technologies applied to the development of biostructures. We focus on novel products for use in spine surgery and in the repair of osteoporotic fra more...
Surgical Specialties Corporation | Address: 100 Dennis Drive, Reading, Pennsylvania 19606, USA
Send Inquiry | Phone: +1-(610)-404-1000
Year Established: 2003 Annual Revenues: USD 10-25 Million Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Sutures, Trephines, Eyelid Specula, Disposables, Corneal Donor Button Punch, Punctum Plugs (Punctal Plugs), ...
Surgical Specialties Corporation provides surgeons with surgical products. We produce and distribute quill medical's self-anchoring suture technology for use in aesthetic & cosmetic surgery. We offer more...
Send Inquiry | Phone: +1-(610)-404-1000
Year Established: 2003 Annual Revenues: USD 10-25 Million Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Sutures, Trephines, Eyelid Specula, Disposables, Corneal Donor Button Punch, Punctum Plugs (Punctal Plugs), ...
Surgical Specialties Corporation provides surgeons with surgical products. We produce and distribute quill medical's self-anchoring suture technology for use in aesthetic & cosmetic surgery. We offer more...
Alphatec Spine, Inc. | Address: 5818 El Camino Real, Carlsbad, California 92008, USA
www.alphatecspine.com | Send Inquiry | Phone: +1-(760)-431-9286, 800-922-1356
FDA Registration: 2027467
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Trays (FDA Code: LRP), Surgical Retractor Systems (FDA Code: GAD), ...
Alphatec Spine, Inc. is a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, primarily focused on the aging spine. We have more...
www.alphatecspine.com | Send Inquiry | Phone: +1-(760)-431-9286, 800-922-1356
FDA Registration: 2027467
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Surgical Trays (FDA Code: LRP), Surgical Retractor Systems (FDA Code: GAD), ...
Alphatec Spine, Inc. is a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, primarily focused on the aging spine. We have more...
Interventional Spine, Inc. | Address: 13700 Alton Pkwy., Suite 160, Irvine, California 92618, USA
www.i-spineinc.com | Send Inquiry | Phone: +1-(949)-472-0006, 800-497-0484
Year Established: 2000
Products: Surgical Retractor Systems (FDA Code: GAD), Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Tissue Retractors, ...
Interventional Spine, Inc. focuses on the design, development and marketing of patented percutaneous systems to treat lower back pain. Our products are intended to bridge the therapeutic continuum of more...
www.i-spineinc.com | Send Inquiry | Phone: +1-(949)-472-0006, 800-497-0484
Year Established: 2000
Products: Surgical Retractor Systems (FDA Code: GAD), Drill Bit (FDA Code: HTW), Bone Taps (FDA Code: HWX), Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Tissue Retractors, ...
Interventional Spine, Inc. focuses on the design, development and marketing of patented percutaneous systems to treat lower back pain. Our products are intended to bridge the therapeutic continuum of more...
Osseon Therapeutics, Inc. | Address: 2330 Circadian Way, Santa Rosa, California 95407, USA
www.osseon.com | Send Inquiry | Phone: +1-(707)-636 5940
Products: Drill Bit (FDA Code: HTW), Tamps (FDA Code: HXG), Instruments for Minimally Invasive Surgery, Osteoporosis Care, Disposable Aspiration and Injection Needle (FDA Code: GAA), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), ...
Osseon™ Therapeutics, Inc. specializes in bone cement delivery devices as well as complementary bone cement composite for treating symptomatic compression fractures of the vertebral spine which more...
www.osseon.com | Send Inquiry | Phone: +1-(707)-636 5940
Products: Drill Bit (FDA Code: HTW), Tamps (FDA Code: HXG), Instruments for Minimally Invasive Surgery, Osteoporosis Care, Disposable Aspiration and Injection Needle (FDA Code: GAA), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), ...
Osseon™ Therapeutics, Inc. specializes in bone cement delivery devices as well as complementary bone cement composite for treating symptomatic compression fractures of the vertebral spine which more...
Medtronic Spine LLC | Address: 1221 Crossman Ave., Sunnyvale, California 94089, USA
www.medtronicspine.com | Send Inquiry | Phone: +1-(408)-548-6500, 877-690-5353
FDA Registration: 2953769 Year Established: 1994
Products: Forceps (FDA Code: HTD), Drill Bit (FDA Code: HTW), Tamps (FDA Code: HXG), Drill Bits & Bone Taps, Cannulated Drill Bit, Anesthetic Conduction Needle with/without Introducer (FDA Code: BSP), ...
Medtronic Spine LLC offers online resource for neck pain, back pain, spinal health and treatment options for the same. Our cervical products for spinal surgery include plates, tissues and interbodies more...
www.medtronicspine.com | Send Inquiry | Phone: +1-(408)-548-6500, 877-690-5353
FDA Registration: 2953769 Year Established: 1994
Products: Forceps (FDA Code: HTD), Drill Bit (FDA Code: HTW), Tamps (FDA Code: HXG), Drill Bits & Bone Taps, Cannulated Drill Bit, Anesthetic Conduction Needle with/without Introducer (FDA Code: BSP), ...
Medtronic Spine LLC offers online resource for neck pain, back pain, spinal health and treatment options for the same. Our cervical products for spinal surgery include plates, tissues and interbodies 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...
Cochlear Americas | Address: 13059 E. Peakview Avenue, Centennial, Colorado 80111, USA
www.cochlear.com | Send Inquiry | Phone: +1-(303)-790 9010/8005235798
FDA Registration: 3005900820 Year Established: 1985 Annual Revenues: USD 100-500 Million Employee Count: ~140 Quality: ISO 9000, CE Certified
Products: Surgical Cochlear Implant (FDA Code: MCM), Bahar Implant System, Bone Conduction Implant, Bahar Sound Processors, Cochlear Implant (FDA Code: MCM), AC-Powered Surgical Instrument Motor (FDA Code: GEY), ...
Cochlear Americas focuses on implantable hearing solutions. We offer innovative, high-quality information on hearing aids including digital hearing aids, hearing loss, cochlear implants and tinnitus. more...
www.cochlear.com | Send Inquiry | Phone: +1-(303)-790 9010/8005235798
FDA Registration: 3005900820 Year Established: 1985 Annual Revenues: USD 100-500 Million Employee Count: ~140 Quality: ISO 9000, CE Certified
Products: Surgical Cochlear Implant (FDA Code: MCM), Bahar Implant System, Bone Conduction Implant, Bahar Sound Processors, Cochlear Implant (FDA Code: MCM), AC-Powered Surgical Instrument Motor (FDA Code: GEY), ...
Cochlear Americas focuses on implantable hearing solutions. We offer innovative, high-quality information on hearing aids including digital hearing aids, hearing loss, cochlear implants and tinnitus. more...
Beekley Corp | Address: One Prestige Lane, Bristol, Connecticut 06010, USA
www.beekley.com | Send Inquiry | Phone: +1-(800)-2335539
Quality: ISO 13485:2003 Certified
Products: Computed Tomography, Adhesive Bandages (FDA Code: KGX), Medical Imaging, Mammography Devices, Positioning System Accessories, Computed Tomography Accessories, ...
Beekley Corp distributes medical imaging equipment. Our pointguards protect longer, more linear temporary marks during radiation therapy treatment. Our self adhesive CT guidelines biopsy grid is used more...
www.beekley.com | Send Inquiry | Phone: +1-(800)-2335539
Quality: ISO 13485:2003 Certified
Products: Computed Tomography, Adhesive Bandages (FDA Code: KGX), Medical Imaging, Mammography Devices, Positioning System Accessories, Computed Tomography Accessories, ...
Beekley Corp distributes medical imaging equipment. Our pointguards protect longer, more linear temporary marks during radiation therapy treatment. Our self adhesive CT guidelines biopsy grid is used more...
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...
Innovia Llc | Address: 12415 S.W. 136th Ave., Unit 3, Miami, Florida 33186, USA
www.innovia-llc.com | Send Inquiry | Phone: +1-(305)-378-2651
Quality: ISO 13485 Certified
Products: Tissue Expander, General & Plastic Surgery Laparoscope (FDA Code: GCJ), Percutaneous Biopsy Device (FDA Code: MJG), Orbital Tissue Expander (FDA Code: NFM), Laparoscopic Ports, ...
Innovia Llc specializes in the development and manufacture of novel biomaterials & medical devices. We focuses on ophthalmology and cardiovascular. Our Innoseal* is a biodegradable stretchy polysaccha more...
www.innovia-llc.com | Send Inquiry | Phone: +1-(305)-378-2651
Quality: ISO 13485 Certified
Products: Tissue Expander, General & Plastic Surgery Laparoscope (FDA Code: GCJ), Percutaneous Biopsy Device (FDA Code: MJG), Orbital Tissue Expander (FDA Code: NFM), Laparoscopic Ports, ...
Innovia Llc specializes in the development and manufacture of novel biomaterials & medical devices. We focuses on ophthalmology and cardiovascular. Our Innoseal* is a biodegradable stretchy polysaccha more...
Pajunk Medical Systems L.P. | Address: 6611 Bay Circle, Suite 100, Norcross, Georgia 30071, USA
www.pajunk.com | Send Inquiry | Phone: +1-(678)-493-6832, 888-972-5865
FDA Registration: 3004076349
Products: Electrocardiographs (ECGs), Catheters, Diagnostic Instruments, Biopsy Instruments (FDA Code: KNW), Bone Marrow Biopsy Needle, Cannulas, ...
Pajunk Medical Systems L.P. is a producer of complete medical systems for the different application-methods in four areas including laparoscopy, regional anaesthesia, biopsy, and dental medicine. The more...
www.pajunk.com | Send Inquiry | Phone: +1-(678)-493-6832, 888-972-5865
FDA Registration: 3004076349
Products: Electrocardiographs (ECGs), Catheters, Diagnostic Instruments, Biopsy Instruments (FDA Code: KNW), Bone Marrow Biopsy Needle, Cannulas, ...
Pajunk Medical Systems L.P. is a producer of complete medical systems for the different application-methods in four areas including laparoscopy, regional anaesthesia, biopsy, and dental medicine. The 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...
Oticon Inc | Address: 29 Schoolhouse Rd, Somerset, New Jersey 08873, USA
www.oticonusa.com | Send Inquiry | Phone: +1-(800)-526 3921
FDA Registration: 2240713 Employee Count: ~350
Products: Digital Hearing Aids, Hearing Aids, Audiometers (FDA Code: EWO), Body-worn Hearing Aids, BTE Hearing Aids, Canal Hearing Aids, ...
Oticon Inc manufactures hearing aid products.. We offer digital hearing instruments using a new audiological rational called adaptive speech alignment. We are an ISO 9001:2000 certified company. Our p more...
www.oticonusa.com | Send Inquiry | Phone: +1-(800)-526 3921
FDA Registration: 2240713 Employee Count: ~350
Products: Digital Hearing Aids, Hearing Aids, Audiometers (FDA Code: EWO), Body-worn Hearing Aids, BTE Hearing Aids, Canal Hearing Aids, ...
Oticon Inc manufactures hearing aid products.. We offer digital hearing instruments using a new audiological rational called adaptive speech alignment. We are an ISO 9001:2000 certified company. Our p 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...
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FDA Code / Regulation: MJG / 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.
