Biopsy Punches Suppliers
Limit companies to: Worldwide USA
Acuderm, Inc | Address: 5370 NW Terrace, Fort Lauderdale, Florida 33309, USA 
acuderm.com | Send Inquiry | Phone: +001-(800)-327-0015
FDA Registration: 1035236 Year Established: 1983 Annual Revenues: USD 5-10 Million Employee Count: ~70 Quality: ISO 9002, CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Powered Surgical Laser Instrument (FDA Code: GEX), Biopsy Punches (FDA Code: FCI), Cauteries, Cold Sterilization Solution, ...
Acuderm, Inc markets quality specialty medical products, disposable instruments and dermatology supplies. Our product line includes punches, curettes, acu excisor, needle, syringes, sutures, hyfrecato more...
acuderm.com | Send Inquiry | Phone: +001-(800)-327-0015
FDA Registration: 1035236 Year Established: 1983 Annual Revenues: USD 5-10 Million Employee Count: ~70 Quality: ISO 9002, CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Powered Surgical Laser Instrument (FDA Code: GEX), Biopsy Punches (FDA Code: FCI), Cauteries, Cold Sterilization Solution, ...
Acuderm, Inc markets quality specialty medical products, disposable instruments and dermatology supplies. Our product line includes punches, curettes, acu excisor, needle, syringes, sutures, hyfrecato more...
HealthLink | Address: 3611 St John's Bluff Rd South, Suite 1, Jacksonville, Florida 32224, USA
www.healthlinkinc.net | Send Inquiry | Phone: +1-(800)-638-2625
FDA Registration: 1059020
Products: Curettes, Hematology Analyzers, Thermometers, Diagnostic Aids, Biopsy Punches (FDA Code: FCI), Blood Analyzer Reagents, ...
HealthLink is a medical manufacturer. We offer a wide range of medical lamps & batteries, stains & reagents and biological indicators. We manufacture a complete line of prepared culture media. This in more...
www.healthlinkinc.net | Send Inquiry | Phone: +1-(800)-638-2625
FDA Registration: 1059020
Products: Curettes, Hematology Analyzers, Thermometers, Diagnostic Aids, Biopsy Punches (FDA Code: FCI), Blood Analyzer Reagents, ...
HealthLink is a medical manufacturer. We offer a wide range of medical lamps & batteries, stains & reagents and biological indicators. We manufacture a complete line of prepared culture media. This in more...
Cameron-Miller, Inc. | Address: 5410 West Roosevelt, Road #241, Chicago, Illinois 60644, USA
cameron-miller.com | Send Inquiry | Phone: +1-(773)-379-2624, 800-621-0142
FDA Registration: 1415191 Year Established: 1915 Annual Revenues: USD 25-50 Million Employee Count: ~20 Quality: ISO 9000 Certified
Products: Forceps (FDA Code: HTD), Surgical Smoke Evacuators, Electrosurgical Generators, Biopsy Punches (FDA Code: FCI), Disposable Loop Electrodes, Disposable Ball Electrodes, ...
Cameron-Miller, Inc. manufactures surgical and medical instruments. Our product line includes electro-surgical generators, forceps, flexible snares, rigid snares, flexible suction coagulators, rigid s more...
cameron-miller.com | Send Inquiry | Phone: +1-(773)-379-2624, 800-621-0142
FDA Registration: 1415191 Year Established: 1915 Annual Revenues: USD 25-50 Million Employee Count: ~20 Quality: ISO 9000 Certified
Products: Forceps (FDA Code: HTD), Surgical Smoke Evacuators, Electrosurgical Generators, Biopsy Punches (FDA Code: FCI), Disposable Loop Electrodes, Disposable Ball Electrodes, ...
Cameron-Miller, Inc. manufactures surgical and medical instruments. Our product line includes electro-surgical generators, forceps, flexible snares, rigid snares, flexible suction coagulators, rigid s more...
Medgyn Products Inc | Address: 328 N Eisenhower Lane, Lombard, Illinois 60148, USA
www.medgyn.com | Send Inquiry | Phone: +1-(630)-627-4105
FDA Registration: 1450908 Year Established: 1975 Annual Revenues: USD 1-5 Million Employee Count: ~60 Quality: ISO 9002, CE Certified
Products: Colposcopes, Endometrial Biopsy Equipment, Curettes, Biopsy Punches (FDA Code: FCI), Blood Collection Needles, General Diagnostic Supplies, ...
Medgyn Products Inc manufactures & distributes quality medical supplies, instruments & equipment that satisfy the needs of the obstetrics and gynecological medical professionals. Our aspiration kits a more...
www.medgyn.com | Send Inquiry | Phone: +1-(630)-627-4105
FDA Registration: 1450908 Year Established: 1975 Annual Revenues: USD 1-5 Million Employee Count: ~60 Quality: ISO 9002, CE Certified
Products: Colposcopes, Endometrial Biopsy Equipment, Curettes, Biopsy Punches (FDA Code: FCI), Blood Collection Needles, General Diagnostic Supplies, ...
Medgyn Products Inc manufactures & distributes quality medical supplies, instruments & equipment that satisfy the needs of the obstetrics and gynecological medical professionals. Our aspiration kits a more...
Universal Footcare Products | Address: 300 Wainwright Drive, Northbrook, Illinois 60062, USA
www.universalfootcare.com | Send Inquiry | Phone: +1-(800)-323-5110
FDA Registration: 3012106760
Products: Splints, Curettes, Retractors, X-Ray Film, Antibiotics & Antibacterials, Antiseptic Solutions, ...
Universal Footcare Products is a distributor of products, equipment and pharmaceuticals to podiatrists & orthopedic surgeons. Our apus is a specially designed inverter type of foot & ankle unit, which more...
www.universalfootcare.com | Send Inquiry | Phone: +1-(800)-323-5110
FDA Registration: 3012106760
Products: Splints, Curettes, Retractors, X-Ray Film, Antibiotics & Antibacterials, Antiseptic Solutions, ...
Universal Footcare Products is a distributor of products, equipment and pharmaceuticals to podiatrists & orthopedic surgeons. Our apus is a specially designed inverter type of foot & ankle unit, which more...
Sterylab USA, LLC | Address: 2916 Graham Rd., Suite C, Franklin, Indiana 46131, USA
Send Inquiry | Phone: +1-(317)-736-8306/736-8069
FDA Registration: 3005561465 Quality: ISO 9001, ISO 13485 Certified
Products: Biopsy Punches (FDA Code: FCI), Disposable Endometrial Biopsy, Endometrial Biopsy Curette, Biopsy Instruments (FDA Code: KNW), Soft Tissue Biopsy Needles, Bone Marrow Biopsy Needle, ...
Sterylab USA, LLC is specialized in the production of medical needles and devices. We offer various types and models of needles to antenatal diagnostic, clinical oncology, gynecology, infection contro more...
Send Inquiry | Phone: +1-(317)-736-8306/736-8069
FDA Registration: 3005561465 Quality: ISO 9001, ISO 13485 Certified
Products: Biopsy Punches (FDA Code: FCI), Disposable Endometrial Biopsy, Endometrial Biopsy Curette, Biopsy Instruments (FDA Code: KNW), Soft Tissue Biopsy Needles, Bone Marrow Biopsy Needle, ...
Sterylab USA, LLC is specialized in the production of medical needles and devices. We offer various types and models of needles to antenatal diagnostic, clinical oncology, gynecology, infection contro more...
Schering-Plough Corporation | Address: 2000 Galloping Hill Road, Kenilworth, New Jersey 07033, USA
www.sch-plough.com | Send Inquiry | Phone: +1-(908)-298-4000
Annual Revenues: USD 100-500 Million Quality: CE Certified
Products: Antibiotics & Antifungal, Antibiotics & Antimicrobials, Antifungals & Antiseborrheics, Antihistamines & Decongestants, Baby Care Items, Biopsy Punches (FDA Code: FCI), ...
Schering-Plough Corporation focuses on the discovery, manufacturing and distribution of medical therapies & treatments. We also sell consumer brands in the over-the-counter (OTC), foot care & sun care more...
www.sch-plough.com | Send Inquiry | Phone: +1-(908)-298-4000
Annual Revenues: USD 100-500 Million Quality: CE Certified
Products: Antibiotics & Antifungal, Antibiotics & Antimicrobials, Antifungals & Antiseborrheics, Antihistamines & Decongestants, Baby Care Items, Biopsy Punches (FDA Code: FCI), ...
Schering-Plough Corporation focuses on the discovery, manufacturing and distribution of medical therapies & treatments. We also sell consumer brands in the over-the-counter (OTC), foot care & sun care more...
Ortho-Med, Inc. | Address: 3208 S.E. 13th Ave., Portland, Oregon 97202, USA
www.orthomedinc.com | Send Inquiry | Phone: +1-(503)-234-9691, 800-547-5571
FDA Registration: 3019455 Year Established: 1970 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Mallets, Chisels, Osteotomes, Suture Passers, Biopsy Punches (FDA Code: FCI), General Surgical Instruments, ...
Ortho-Med, Inc. specializes in surgical instruments. Our product list comprises of wire & pin implants, spinal rongeurs & punches, bone curettes, osteotomes, chisels and bone files. Our hot or cold ve more...
www.orthomedinc.com | Send Inquiry | Phone: +1-(503)-234-9691, 800-547-5571
FDA Registration: 3019455 Year Established: 1970 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Mallets, Chisels, Osteotomes, Suture Passers, Biopsy Punches (FDA Code: FCI), General Surgical Instruments, ...
Ortho-Med, Inc. specializes in surgical instruments. Our product list comprises of wire & pin implants, spinal rongeurs & punches, bone curettes, osteotomes, chisels and bone files. Our hot or cold ve more...
Premier Products Co. | Address: 1710 Romano Drive, Plymouth Meeting, Pennsylvania 19462, USA
www.premusa.com | Send Inquiry | Phone: +1-(888)-239-6000
FDA Registration: 2521453 Year Established: 1980 Quality: ISO 9001, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Curettes, Retractors, Scissors, Uterine Sound Instruments, Biopsy Punches (FDA Code: FCI), ...
Premier Products Co. manufactures & distributes health care products. We are an ISO 9001:2000 and ISO 13485:2003 certified company. The premier evacuator/air filtration system with its distinctly quie more...
www.premusa.com | Send Inquiry | Phone: +1-(888)-239-6000
FDA Registration: 2521453 Year Established: 1980 Quality: ISO 9001, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Curettes, Retractors, Scissors, Uterine Sound Instruments, Biopsy Punches (FDA Code: FCI), ...
Premier Products Co. manufactures & distributes health care products. We are an ISO 9001:2000 and ISO 13485:2003 certified company. The premier evacuator/air filtration system with its distinctly quie more...
Gynex Corporation | Address: 2789 - 152nd Avenue Ne, Redmond, Washington 98052, USA
www.gynex.com | Send Inquiry | Phone: +1-(425)-882-1179, 800-220-5988
FDA Registration: 3032109
Products: Colposcopes, Vaginal Retractors (FDA Code: HDL), Clamps, Forceps (FDA Code: HTD), Scissors, Tubing, ...
Gynex Corporation specializes in providing OB/GYN instruments and equipment to customers worldwide. We offer anesthetic, biopsy punches, clamps, cleaning supplies, colposcopes, curettes, dilators, fet more...
www.gynex.com | Send Inquiry | Phone: +1-(425)-882-1179, 800-220-5988
FDA Registration: 3032109
Products: Colposcopes, Vaginal Retractors (FDA Code: HDL), Clamps, Forceps (FDA Code: HTD), Scissors, Tubing, ...
Gynex Corporation specializes in providing OB/GYN instruments and equipment to customers worldwide. We offer anesthetic, biopsy punches, clamps, cleaning supplies, colposcopes, curettes, dilators, fet more...
Schuco International (London) Ltd. | Address: Challenge House, #1 Lyndhurst Avenue, London N12 0NE, United Kingdom 
www.schuco.co.uk | Send Inquiry | Phone: +44-(20)-8368-1642
Year Established: 1957 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9002, CE Certified
Products: Splints, Bipolar Forceps, Tissue Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Loupes, Iris Scissors, ...
Schuco International (London) Ltd. is a supplier of equipment for all skin technologies. Our primary focus is in the field of dermatology. Our product list comprises of biopsy punch & curettes, reusab more...
www.schuco.co.uk | Send Inquiry | Phone: +44-(20)-8368-1642
Year Established: 1957 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9002, CE Certified
Products: Splints, Bipolar Forceps, Tissue Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Loupes, Iris Scissors, ...
Schuco International (London) Ltd. is a supplier of equipment for all skin technologies. Our primary focus is in the field of dermatology. Our product list comprises of biopsy punch & curettes, reusab more...
Northumbrian Medical Supplies Ltd. | Address: Unit 18A - 18B, Airport Industrial Estate, Kingston Park, Newcastle Upon Tyne, England NE3 2EF, United Kingdom
www.normedica.co.uk | Send Inquiry | Phone: +44-(0191)-2867799
Products: Hypodermic Needles, Otoscopes, Forceps (FDA Code: HTD), Biopsy Punches (FDA Code: FCI), Blood Pressure Monitors, Stethoscopes, ...
Northumbrian Medical Supplies Ltd. offers Dopplers, ampoule holders, blood pressure monitors, and autoclaves. Our Spirometer has 6000 test memory, and is provided with a high resolution color screen, more...
www.normedica.co.uk | Send Inquiry | Phone: +44-(0191)-2867799
Products: Hypodermic Needles, Otoscopes, Forceps (FDA Code: HTD), Biopsy Punches (FDA Code: FCI), Blood Pressure Monitors, Stethoscopes, ...
Northumbrian Medical Supplies Ltd. offers Dopplers, ampoule holders, blood pressure monitors, and autoclaves. Our Spirometer has 6000 test memory, and is provided with a high resolution color screen, more...
Combined Instruments (Pvt.), Ltd. | Address: 13-A Model Town, Ugoki, Sailkot, Pakistan
Phone: +92-(432)-510243
Products: Vaginal Retractors (FDA Code: HDL), Blood Lancets, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Uterine Sound Instruments, Lacrimal Dilators and Cannulas, ...
Combined Instruments (Pvt.), Ltd. is a manufacturer and exporter of general surgery instruments. Our products include cotton applicators, scalpel blades, depth gauge, ear speculum holders, biopsy & su more...
Phone: +92-(432)-510243
Products: Vaginal Retractors (FDA Code: HDL), Blood Lancets, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Uterine Sound Instruments, Lacrimal Dilators and Cannulas, ...
Combined Instruments (Pvt.), Ltd. is a manufacturer and exporter of general surgery instruments. Our products include cotton applicators, scalpel blades, depth gauge, ear speculum holders, biopsy & su more...
HMNGB Crocomed Technik Inc. | Address: Mustafa town, Small Industrial Estate,, Sialkot, Punjab 51310, Pakistan
www.hmngbcrocomed.com | Send Inquiry | Phone: +92-(52)-3258199
Quality: ISO 9001:2008, CE, ISO 13485, cGMP Certified
Products: Biopsy Capsules & Punches, Gynecology Instruments, Micro Surgery Instruments, Fixation Forceps, Foreign Body Forceps, Kerrison Punches, ...
HMNGB Crocomed Technik Inc. is a manufacturer of various surgery, ENT and endoscopy shafts and tube shafts instruments made with imported stainless steel materials. Our bone surgery products include t more...
www.hmngbcrocomed.com | Send Inquiry | Phone: +92-(52)-3258199
Quality: ISO 9001:2008, CE, ISO 13485, cGMP Certified
Products: Biopsy Capsules & Punches, Gynecology Instruments, Micro Surgery Instruments, Fixation Forceps, Foreign Body Forceps, Kerrison Punches, ...
HMNGB Crocomed Technik Inc. is a manufacturer of various surgery, ENT and endoscopy shafts and tube shafts instruments made with imported stainless steel materials. Our bone surgery products include t more...
Bashir, Jamil & Bros. Pvt. Ltd. | Address: P.O. Box 7, Khadim Ali Road, Sialkot, Punjab 51310, Pakistan
Send Inquiry | Phone: +92-(432)-3554-100
FDA Registration: 8040179 Year Established: 1957 Annual Revenues: USD 5-10 Million Employee Count: ~320 Quality: ISO 9001:2008, ISO 13485:2003, CE Certified
Products: Pelvimeters, Vaginal Retractors (FDA Code: HDL), Fixation Forceps, Tissue Forceps, Kremer Fixation Forceps, Double Prong Skin Hooks, ...
Bashir, Jamil & Bros. Pvt. Ltd. is a manufacturer and exporter of manicure, surgical, scissors, dental instruments and metal fabrication of vetrinary & postmortem instruments. more...
Send Inquiry | Phone: +92-(432)-3554-100
FDA Registration: 8040179 Year Established: 1957 Annual Revenues: USD 5-10 Million Employee Count: ~320 Quality: ISO 9001:2008, ISO 13485:2003, CE Certified
Products: Pelvimeters, Vaginal Retractors (FDA Code: HDL), Fixation Forceps, Tissue Forceps, Kremer Fixation Forceps, Double Prong Skin Hooks, ...
Bashir, Jamil & Bros. Pvt. Ltd. is a manufacturer and exporter of manicure, surgical, scissors, dental instruments and metal fabrication of vetrinary & postmortem instruments. more...
Gima S.P.A. | Address: Via Monza, 102, Gessate, MI 20060, Italy
www.gimaitaly.com | Send Inquiry | Phone: +39-(02)-953854209/221/225
Annual Revenues: USD 5-10 Million Employee Count: ~20 Quality: ISO 9002, CE Certified
Products: Biopsy Punches (FDA Code: FCI), Neurological Hammer, Adult Stethoscope, Electrodes and Other Components, Gold Cup Electrodes, Urine Strips, Needle Destroyer, ...
Gima S.P.A. is manufacturer of metal and glass syringes. Our product line includes thermometers, diagnostic tests, medical disposables, bags, scales, wheelchairs, patient aids, trolleys, beds, furnitu more...
www.gimaitaly.com | Send Inquiry | Phone: +39-(02)-953854209/221/225
Annual Revenues: USD 5-10 Million Employee Count: ~20 Quality: ISO 9002, CE Certified
Products: Biopsy Punches (FDA Code: FCI), Neurological Hammer, Adult Stethoscope, Electrodes and Other Components, Gold Cup Electrodes, Urine Strips, Needle Destroyer, ...
Gima S.P.A. is manufacturer of metal and glass syringes. Our product line includes thermometers, diagnostic tests, medical disposables, bags, scales, wheelchairs, patient aids, trolleys, beds, furnitu more...
Sterylab S.R.L. | Address: Via Magenta, 77/6, Rho, MI 20017, Italy
www.sterylab.it | Send Inquiry | Phone: +39-(02)-93 50 84 27
FDA Registration: 3007748770 Annual Revenues: USD 5-10 Million Employee Count: ~20 Quality: ISO 9001 and 13485, CE Certified
Products: MRI Imaging, Biopsy Punches (FDA Code: FCI), Disposable Needles, Biopsy Instruments (FDA Code: KNW), Soft Tissue Biopsy Needles, Bone Marrow Biopsy Needle, ...
Sterylab S.R.L. is a provider of medical needles and devices. We offer products for antenatal diagnostic, clinical oncology, gynecology, infection control, interventional radiology, mammography, urolo more...
www.sterylab.it | Send Inquiry | Phone: +39-(02)-93 50 84 27
FDA Registration: 3007748770 Annual Revenues: USD 5-10 Million Employee Count: ~20 Quality: ISO 9001 and 13485, CE Certified
Products: MRI Imaging, Biopsy Punches (FDA Code: FCI), Disposable Needles, Biopsy Instruments (FDA Code: KNW), Soft Tissue Biopsy Needles, Bone Marrow Biopsy Needle, ...
Sterylab S.R.L. is a provider of medical needles and devices. We offer products for antenatal diagnostic, clinical oncology, gynecology, infection control, interventional radiology, mammography, urolo more...
Rema Medizintechnik Gmbh | Address: In Breiten 10, Duerbheim / Tuttlingen D-78589, Germany 
www.rema-surgery.de | Send Inquiry | Phone: +49-(7424)-981053-0
Year Established: 1971 Annual Revenues: USD 5-10 Million Employee Count: ~20 Quality: ISO 9000, ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Suction Tubes, Gastroenterologic Needle Holder (FDA Code: FHQ), Biopsy Forceps Femoral Approach, Biopsy Forceps, Internal Jugular Approach, Arthroscopes (FDA Code: HRX), ...
Rema Medizintechnik Gmbh is a developer, manufacturer and distributor of instruments & equipment for endoscopy, arthroscopy, laparoscopy, thoracoscopy, gynecology and urology. The excaliber arthroscop more...
www.rema-surgery.de | Send Inquiry | Phone: +49-(7424)-981053-0
Year Established: 1971 Annual Revenues: USD 5-10 Million Employee Count: ~20 Quality: ISO 9000, ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Suction Tubes, Gastroenterologic Needle Holder (FDA Code: FHQ), Biopsy Forceps Femoral Approach, Biopsy Forceps, Internal Jugular Approach, Arthroscopes (FDA Code: HRX), ...
Rema Medizintechnik Gmbh is a developer, manufacturer and distributor of instruments & equipment for endoscopy, arthroscopy, laparoscopy, thoracoscopy, gynecology and urology. The excaliber arthroscop more...
Schad Medical Instruments Gmbh | Address: Hegaustrasse 9, Neuhausen 1 78759, Germany
www.smi-schad.de | Send Inquiry | Phone: +49-(7467)-94610
FDA Registration: 8010871
Products: Uterine Sound Instruments, Gastroenterologic Needle Holder (FDA Code: FHQ), Biopsy Punches (FDA Code: FCI), Tongue Depressors (FDA Code: FMA), Disposable Biopsy Punch, Elliptical Biopsy Punch, ...
Schad Medical Instruments Gmbh specializes in surgical instruments used in general surgery, plastic, gastroenterology, urology and orthopedic surgery. more...
www.smi-schad.de | Send Inquiry | Phone: +49-(7467)-94610
FDA Registration: 8010871
Products: Uterine Sound Instruments, Gastroenterologic Needle Holder (FDA Code: FHQ), Biopsy Punches (FDA Code: FCI), Tongue Depressors (FDA Code: FMA), Disposable Biopsy Punch, Elliptical Biopsy Punch, ...
Schad Medical Instruments Gmbh specializes in surgical instruments used in general surgery, plastic, gastroenterology, urology and orthopedic surgery. more...
Seifring - Instrumente GmbH | Address: Gunninger Str. 35, Seitingen-Oberflacht 78606, Germany
Products: Vaginal Retractors (FDA Code: HDL), Saws (FDA Code: HSO), Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, Biopsy Punches (FDA Code: FCI), ...
Seifring - Instrumente GmbH specializes in offering hemostatic clips. Our products include self-retaining retractors, vaginal dilators, bone cutting forceps, surgical hammer, bone holding forceps, abd more...
Products: Vaginal Retractors (FDA Code: HDL), Saws (FDA Code: HSO), Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, Biopsy Punches (FDA Code: FCI), ...
Seifring - Instrumente GmbH specializes in offering hemostatic clips. Our products include self-retaining retractors, vaginal dilators, bone cutting forceps, surgical hammer, bone holding forceps, abd more...
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FDA Code / Regulation: FCI / 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).
