Biopsy Instruments 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...
Advanced Bionics Corporation | Address: 12740 San Fernando Road, Sylmar, California 91342, USA
www.advancedbionics.com | Send Inquiry | Phone: +1-(661)-362-1400
FDA Registration: 3006556115
Products: Batteries, Vaginal Retractors (FDA Code: HDL), Gastroenterologic Needle Holder (FDA Code: FHQ), Catheter Introducers (FDA Code: DYB), Magnetic Stimulators, Urethral Catheters (FDA Code: GBM), ...
Advanced Bionics Corporation focuses on the development of implantable, high-technology neuro stimulation devices. We concentrate in the manufacture of cochlear implant technology (restores hearing to more...
www.advancedbionics.com | Send Inquiry | Phone: +1-(661)-362-1400
FDA Registration: 3006556115
Products: Batteries, Vaginal Retractors (FDA Code: HDL), Gastroenterologic Needle Holder (FDA Code: FHQ), Catheter Introducers (FDA Code: DYB), Magnetic Stimulators, Urethral Catheters (FDA Code: GBM), ...
Advanced Bionics Corporation focuses on the development of implantable, high-technology neuro stimulation devices. We concentrate in the manufacture of cochlear implant technology (restores hearing to more...
Autosuture | Address: 150 Glover Avenue, Norwalk, Connecticut 06856, USA
www.autosuture.com | Send Inquiry | Phone: +1-(800)-722-8772
Annual Revenues: > USD 1 Billion Employee Count: ~5780 Quality: ISO 9001, ISO 9002, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Retractors, Scissors, Sutures, Needles, ...
Autosuture offers a complete line of surgical products and instrumentation that surgeons utilize for laparoscopic, endoscopic & traditional open surgical procedures & lymphatic mapping. We are an ISO more...
www.autosuture.com | Send Inquiry | Phone: +1-(800)-722-8772
Annual Revenues: > USD 1 Billion Employee Count: ~5780 Quality: ISO 9001, ISO 9002, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Retractors, Scissors, Sutures, Needles, ...
Autosuture offers a complete line of surgical products and instrumentation that surgeons utilize for laparoscopic, endoscopic & traditional open surgical procedures & lymphatic mapping. We are an ISO 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...
Marina Medical Instruments Inc. | Address: 955 Shotgun Rd, Sunrise, Florida 33326, USA
www.marinamedical.com | Send Inquiry | Phone: +1-(954)-924-4418, 800-697-1119
FDA Registration: 2084346 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Vaginal Retractors (FDA Code: HDL), Curettes, Forceps (FDA Code: HTD), Retractors, Hemostatic Mosquito Forceps, Bone Cutters, ...
Marina Medical Instruments Inc. supplies medical instruments. Our product range comprises of vaginal agenesis, fan retractors, pelvic surgery, surgical caps, scopes, electrosurgical, cystoscopy & bari more...
www.marinamedical.com | Send Inquiry | Phone: +1-(954)-924-4418, 800-697-1119
FDA Registration: 2084346 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Vaginal Retractors (FDA Code: HDL), Curettes, Forceps (FDA Code: HTD), Retractors, Hemostatic Mosquito Forceps, Bone Cutters, ...
Marina Medical Instruments Inc. supplies medical instruments. Our product range comprises of vaginal agenesis, fan retractors, pelvic surgery, surgical caps, scopes, electrosurgical, cystoscopy & bari more...
Remington Medical, Inc. | Address: 6830 Meadowridge Court, Alpharetta, Georgia 30005, USA
www.remmed.com | Send Inquiry | Phone: +1-(800)-989-0057
FDA Registration: 3001676837
Products: Procedure Trays, Needles, Catheter Introducers (FDA Code: DYB), Prostate Biopsy Needles, Syringe/Needle Combos, Biopsy Instruments (FDA Code: KNW), ...
Remington Medical Inc. manufactures and distributes disposable medical products such as cardiovascular pacing cables & adapters, core tissue biopsy, aspiration biopsy, brachytherapy, introducer, bone more...
www.remmed.com | Send Inquiry | Phone: +1-(800)-989-0057
FDA Registration: 3001676837
Products: Procedure Trays, Needles, Catheter Introducers (FDA Code: DYB), Prostate Biopsy Needles, Syringe/Needle Combos, Biopsy Instruments (FDA Code: KNW), ...
Remington Medical Inc. manufactures and distributes disposable medical products such as cardiovascular pacing cables & adapters, core tissue biopsy, aspiration biopsy, brachytherapy, introducer, bone more...
Vyaire Medical, Inc. | Address: 26125 North Riverwoods Blvd, Mettawa, Illinois 60045, USA
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Fetal Monitors, Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Hematology Analyzers, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l more...
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Fetal Monitors, Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Hematology Analyzers, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l more...
Cook Group Incorporated | Address: P.O. Box 489, Bloomington, Indiana 47402-0489, USA
www.cookgroup.com | Phone: +1-(812)-339-2235, 800-457-4500
FDA Registration: 1820334 Employee Count: ~340 Quality: ISO 9000, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, Needles, Guidewires, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Cook Group Incorporated focuses on the research and product development in minimally invasive medical device technology for diagnostic & therapeutic procedures. Our wire-guided arndt endobronchial blo more...
www.cookgroup.com | Phone: +1-(812)-339-2235, 800-457-4500
FDA Registration: 1820334 Employee Count: ~340 Quality: ISO 9000, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, Needles, Guidewires, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Cook Group Incorporated focuses on the research and product development in minimally invasive medical device technology for diagnostic & therapeutic procedures. Our wire-guided arndt endobronchial blo more...
Cook Urological | Address: 1100 West Morgan Street,P.O. Box 227, Spencer, Indiana 47460, USA
www.cookurological.com | Phone: +1-(812)-829-4891
FDA Registration: 1825146
Products: Hysteroscopic Equipment, Powered Surgical Laser Instrument (FDA Code: GEX), Biopsy Forceps, Cytology Brushes, Grasping Forceps, Urethral Catheters (FDA Code: GBM), ...
Cook Urological provides professionals in urological health care with medical products, employing the minimally invasive diagnostic and therapeutic device technologies, already proven clinically in ca more...
www.cookurological.com | Phone: +1-(812)-829-4891
FDA Registration: 1825146
Products: Hysteroscopic Equipment, Powered Surgical Laser Instrument (FDA Code: GEX), Biopsy Forceps, Cytology Brushes, Grasping Forceps, Urethral Catheters (FDA Code: GBM), ...
Cook Urological provides professionals in urological health care with medical products, employing the minimally invasive diagnostic and therapeutic device technologies, already proven clinically in ca more...
Ranfac Corp. | Address: 30 Doherty Avenue, P.O. Box 635, Avon, Massachusetts 02322, USA
www.ranfac.com | Send Inquiry | Phone: +1-(508)-588-4400, (800)-272-6322
FDA Registration: 3011555966 Year Established: 1888 Annual Revenues: USD 10-25 Million Employee Count: ~50 Quality: ISO, CE Certified
Products: Hypodermic Needles, Catheter Stylets (FDA Code: DRB), Thrombectomy Devices, Infusion Catheter, Infusion Catheter (FDA Code: JCY), Reusable Hypodermic Needles, Stainless Steel Brain Biopsy Needles, ...
Ranfac Corp. supplies precision medical instruments for surgeons, radiologists and hematologists. Our product list comprises of disposable cholangiography catheters, percutaneous introducers, galactog more...
www.ranfac.com | Send Inquiry | Phone: +1-(508)-588-4400, (800)-272-6322
FDA Registration: 3011555966 Year Established: 1888 Annual Revenues: USD 10-25 Million Employee Count: ~50 Quality: ISO, CE Certified
Products: Hypodermic Needles, Catheter Stylets (FDA Code: DRB), Thrombectomy Devices, Infusion Catheter, Infusion Catheter (FDA Code: JCY), Reusable Hypodermic Needles, Stainless Steel Brain Biopsy Needles, ...
Ranfac Corp. supplies precision medical instruments for surgeons, radiologists and hematologists. Our product list comprises of disposable cholangiography catheters, percutaneous introducers, galactog more...
Hologic Inc | Address: 35 Crosby Drive, Bedford, Massachusetts 01730, USA
www.hologic.com | Send Inquiry | Phone: +1-(781)-999-7300
FDA Registration: 1220984 Year Established: 1985
Products: Contract Manufacturers, Needles, Fluoroscopy Systems, Fluoroscopic Imaging Systems, Portable Fluoroscopes, Digital Mammography Systems, ...
Hologic Inc develops, manufactures and supplies premium diagnostic & medical imaging systems dedicated to serve the healthcare needs of women. We produce digital imaging technology for general radiogr more...
www.hologic.com | Send Inquiry | Phone: +1-(781)-999-7300
FDA Registration: 1220984 Year Established: 1985
Products: Contract Manufacturers, Needles, Fluoroscopy Systems, Fluoroscopic Imaging Systems, Portable Fluoroscopes, Digital Mammography Systems, ...
Hologic Inc develops, manufactures and supplies premium diagnostic & medical imaging systems dedicated to serve the healthcare needs of women. We produce digital imaging technology for general radiogr more...
Stryker | Address: 2825 Airview Boulevard, Kalamazoo, Michigan 49002, USA
www.stryker.com/en-us/index.htm | Phone: +1-(269)-385-2600
Products: Insufflators, Saws (FDA Code: HSO), Light Sources, Bipolar Forceps, Titanium Plating Systems, Bone Drills, ...
Stryker offers a full range of laparoscopic products that meet the performance needed by surgeons. From the uniform image created by our laparoscopes to our StrykeFlow II suction irrigation system, we more...
www.stryker.com/en-us/index.htm | Phone: +1-(269)-385-2600
Products: Insufflators, Saws (FDA Code: HSO), Light Sources, Bipolar Forceps, Titanium Plating Systems, Bone Drills, ...
Stryker offers a full range of laparoscopic products that meet the performance needed by surgeons. From the uniform image created by our laparoscopes to our StrykeFlow II suction irrigation system, we more...
Medtronic, Inc. | Address: 710 Medtronic Parkway, Minneapolis, Minnesota 55432-5604, USA
www.medtronic.com | Send Inquiry | Phone: +1-(763)-514-4000, 800-633-8766
FDA Registration: 2182208 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~50 Quality: CE Certified
Products: Defibrillators, Forceps (FDA Code: HTD), Microdiscectomy Tools, Standard CRT, Odontoid Fixation, pH Monitoring System, ...
Medtronic, Inc. specializes in medical technology, thus providing lifelong solutions for people with chronic pain. We focus on cardiac rhythm disease management (CRDM), spinal & biologics, cardiovascu more...
www.medtronic.com | Send Inquiry | Phone: +1-(763)-514-4000, 800-633-8766
FDA Registration: 2182208 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~50 Quality: CE Certified
Products: Defibrillators, Forceps (FDA Code: HTD), Microdiscectomy Tools, Standard CRT, Odontoid Fixation, pH Monitoring System, ...
Medtronic, Inc. specializes in medical technology, thus providing lifelong solutions for people with chronic pain. We focus on cardiac rhythm disease management (CRDM), spinal & biologics, cardiovascu more...
Minnetronix, Inc. | Address: 1635 Energy Park Drive, St. Paul, Minnesota 55108, USA
www.minnetronix.com | Send Inquiry | Phone: +1-(651)-917-4060
FDA Registration: 2133810
Products: Product Design & Development, Powered Surgical Laser Instrument (FDA Code: GEX), Biopsy Instruments (FDA Code: KNW), Biopsy Instruments (FDA Code: KNW), Atherectomy Coronary Catheter (FDA Code: MCX), Atherectomy Peripheral Catheter (FDA Code: MCW), ...
Minnetronix, Inc. provides high-quality design, engineering, and manufacturing services to medical device companies with software and electronics-based products. We are accredited with ISO 13485:2003 more...
www.minnetronix.com | Send Inquiry | Phone: +1-(651)-917-4060
FDA Registration: 2133810
Products: Product Design & Development, Powered Surgical Laser Instrument (FDA Code: GEX), Biopsy Instruments (FDA Code: KNW), Biopsy Instruments (FDA Code: KNW), Atherectomy Coronary Catheter (FDA Code: MCX), Atherectomy Peripheral Catheter (FDA Code: MCW), ...
Minnetronix, Inc. provides high-quality design, engineering, and manufacturing services to medical device companies with software and electronics-based products. We are accredited with ISO 13485:2003 more...
Ethicon, Inc. | Address: P.O. Box 151,Route 22 West, Somerville, New Jersey 08876, USA
www.ethicon.com | Send Inquiry | Phone: +1-(800)-888-9234
FDA Registration: 3003702646 Employee Count: ~9000
Products: Umbilical Tapes, Forceps (FDA Code: HTD), Scissors, Sutures, Surgicel, Dissectors, ...
Ethicon, Inc. is a global medical device company, which specializes in surgical sutures. Our product portfolio comprises of aesthetic medicine, biosurgicals, hernia solutions, infection control, pelvi more...
www.ethicon.com | Send Inquiry | Phone: +1-(800)-888-9234
FDA Registration: 3003702646 Employee Count: ~9000
Products: Umbilical Tapes, Forceps (FDA Code: HTD), Scissors, Sutures, Surgicel, Dissectors, ...
Ethicon, Inc. is a global medical device company, which specializes in surgical sutures. Our product portfolio comprises of aesthetic medicine, biosurgicals, hernia solutions, infection control, pelvi more...
Ethicon Endo-Surgery, Inc. | Address: 4545 Creek Road, Cincinnati, Ohio 45242-2839, USA
www.ethiconendo.com | Send Inquiry | Phone: +1-(513)-337-8901, (800)-873-3636
FDA Registration: 3005075853 Annual Revenues: USD 1-5 Million Employee Count: ~3000 Quality: CE Certified
Products: Clamps, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Procedure Trays, Retractors, Tissue Forceps, ...
Ethicon Endo-Surgery, Inc. produces & markets advanced medical devices for minimally invasive and open surgical procedures. We offer products like brest care products, surgical stapling products, ener more...
www.ethiconendo.com | Send Inquiry | Phone: +1-(513)-337-8901, (800)-873-3636
FDA Registration: 3005075853 Annual Revenues: USD 1-5 Million Employee Count: ~3000 Quality: CE Certified
Products: Clamps, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Procedure Trays, Retractors, Tissue Forceps, ...
Ethicon Endo-Surgery, Inc. produces & markets advanced medical devices for minimally invasive and open surgical procedures. We offer products like brest care products, surgical stapling products, ener more...
GI Supply | Address: 200 Grandview Avenue, Camp Hill, Pennsylvania 17011-1706, USA
www.gi-supply.com | Send Inquiry | Phone: +1-(717)-761-1170
FDA Registration: 2529592 Quality: CE Certified
Products: Helicobacter pylori Urease Test Kits, Surgical Gowns, Patient Examination Gowns and Capes (FDA Code: FME), Biopsy Instruments (FDA Code: KNW), Airways & Bite Blocks, Oral Airways, Airways & Bite Blocks, Bite Guards and Blocks, ...
GI Supply is a division of Chek Med Systems, which produces disposable medical devices. We offer products like polar wand, spot, viaduct, scopetote, garments, Hpfast/Hpone & biteblocks. Our helicobact more...
www.gi-supply.com | Send Inquiry | Phone: +1-(717)-761-1170
FDA Registration: 2529592 Quality: CE Certified
Products: Helicobacter pylori Urease Test Kits, Surgical Gowns, Patient Examination Gowns and Capes (FDA Code: FME), Biopsy Instruments (FDA Code: KNW), Airways & Bite Blocks, Oral Airways, Airways & Bite Blocks, Bite Guards and Blocks, ...
GI Supply is a division of Chek Med Systems, which produces disposable medical devices. We offer products like polar wand, spot, viaduct, scopetote, garments, Hpfast/Hpone & biteblocks. Our helicobact 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...
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FDA Code / Regulation: KNW / 876.1075
A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Classification. (1) Class II (performance standards).
