Forceps, Biopsy, Non-Electric
FDA product code FCL · Class I (low risk) · 21 CFR 876.1075 · Gastroenterology, Urology
39510(k) clearances
0PMA approvals
11recalls
Manufacturers
- Symbiosis Corp. 3
- Cox Medical Ent., Inc. 3
- C.R. Bard, Inc. 3
- Mill-Rose Laboratory 2
- Spectrascience, Inc. 2
- Portlyn Corp. 2
- Esco Precision, Inc. 2
- Zinnanti Surgical Instruments, Inc. 1
- Endo-Scientific, Inc. 1
- Penn Medical Devices, Inc. 1
- Frantz Medical Development, Ltd. 1
- Gobbs Medical, Inc. 1
- Surgitek Medical Engineering Corp. 1
- Hobbs Medical, Inc. 1
- Jayco Pharmaceuticals 1
- Endo-Therapeutics, Inc. 1
- The Olympus Optical Co. 1
- KARL STORZ Endoscopy-America, Inc. 1
- Dawn Medical 1
- American Endoscopy, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K032092 | Olympus XCYF-TP3 Cystofiberscope/NephrofiberscopeFCL · Traditional | Olympus Optical Co., Ltd. | 07/16/2003SE |
| K973611 | Spectrascience Reusable Biopsy ForcepsFCL · Traditional | Spectrascience, Inc. | 12/02/1997SE |
| K971315 | Auxiliary Instruments for UrsFCL · Traditional | Richard Wolf Medical Instruments Corp. | 09/15/1997SE |
| K964120 | Injecto FlushFCL · Traditional | Robert J. Jynch, Jr. | 12/30/1996SE |
| K963517 | Spectra Science Biopsy ForcepsFCL · Traditional | Spectrascience, Inc. | 12/02/1996SE |
| K955065 | Olympus FB Series Biopsy ForcepsFCL · Traditional | Olympus America, Inc. | 01/24/1996SE |
| K952863 | Forceps, Biopsy, Non-ElectricFCL · Traditional | Annex Medical, Inc. | 07/19/1995SE |
| K952391 | Dynabite Urological ForcepsFCL · Traditional | Portlyn Corp. | 06/01/1995SE |
| K951048 | Rite-Bite Biopsy ForcepsFCL · Traditional | Mill-Rose Laboratory | 03/15/1995SE |
| K946360 | Modular Biopsy ForcepFCL · Traditional | Cox Medical Ent., Inc. | 03/06/1995SE |
| K950559 | Diener Retrieval DevicesFCL · Traditional | Mill-Rose Laboratory | 02/16/1995SE |
| K946238 | Symbiosis Gastrointestinal Biopsy ForcepsFCL · Traditional | Symbiosis Corp. | 01/20/1995SE |
| K944770 | LSVP International Biopsy ForcepsFCL · Traditional | Lsvp Intl., Inc. | 10/13/1994SE |
| K941816 | Emc Flexible Biopsy ForcepsFCL · Traditional | Enterprise Medical Corp. | 07/13/1994SE |
| K941359 | Gip/Medi-Globe Biopsy ForcepsFCL · Traditional | Medi-Globe Corp. | 07/12/1994SE |
| K933135 | Dawn Disposable Biopsy ForcepsFCL · Traditional | Dawn Medical | 03/07/1994SE |
| K931957 | Symbiosis Disposable Urological Biopsy ForcepsFCL · Traditional | Symbiosis Corp. | 02/28/1994SE |
| K935070 | Grasping Forceps, Biopsy Forceps, Spoon ForcepsFCL · Traditional | KARL STORZ Endoscopy-America, Inc. | 01/25/1994SE |
| K935250 | Accu-PathFCL · Traditional | Cox Medical Ent., Inc. | 01/21/1994SE |
| K934186 | Forceps, Biopsy, GastrointestinalFCL · Traditional | Primed Instruments, Inc. | 12/14/1993SE |
| K925392 | Biopsy ForcepsFCL · Traditional | Endo-Therapeutics, Inc. | 11/05/1993SE |
| K932265 | Symbiosis Dispos Pulmon Biopsy Forceps W/Reus HandFCL · Traditional | Symbiosis Corp. | 08/09/1993SE |
| K922396 | Fujinon Forceps -- ModificationFCL · Traditional | Hobbs Medical, Inc. | 12/10/1992SE |
| K914497 | Biopsy ForcepsFCL · Traditional | Surgitek Medical Engineering Corp. | 01/03/1992SE |
| K914212 | Bard Singular Biopsy ForcepsFCL · Traditional | C.R. Bard, Inc. | 11/27/1991SE |
| K913883 | Cox Disposable Biopsy ForcepFCL · Traditional | Cox Medical Ent., Inc. | 10/05/1991SE |
| K912549 | Bard(R) Disposable Biopsy ForcepsFCL · Traditional | C.R. Bard, Inc. | 09/10/1991SE |
| K912214 | Bard Singular Biopsy ForcepsFCL · Traditional | C.R. Bard, Inc. | 05/30/1991SE |
| K896147 | Biopsy Forcep (Non-Electric)FCL · Traditional | Portlyn Corp. | 04/16/1990SE |
| K893636 | Guardian ForcepFCL · Traditional | Endo-Scientific, Inc. | 04/09/1990SE |
| K900065 | Non-Electric Biopsy ForcepsFCL · Traditional | Esco Precision, Inc. | 03/15/1990SE |
| K900015 | Non-Electric Biopsy ForcepsFCL · Traditional | Esco Precision, Inc. | 03/15/1990SE |
| K892252 | Biopsy ForcepsFCL · Traditional | Zinnanti Surgical Instruments, Inc. | 10/03/1989SE |
| K873176 | Huffman Biopsy UnitFCL · Traditional | Penn Medical Devices, Inc. | 10/14/1987SE |
| K871710 | Biopsy ForcepsFCL · Traditional | Frantz Medical Development, Ltd. | 08/10/1987SE |
| K844551 | Hobbs Medical /Jayco Multiple Biopsy InstrumentFCL · Traditional | Gobbs Medical, Inc. | 01/03/1985SE |
| K844690 | Endoscopic Multiple Biopsy InstrumentFCL · Traditional | Jayco Pharmaceuticals | 01/02/1985SE |
| K840818 | Biopsy ForcepsFCL · Traditional | American Endoscopy, Inc. | 04/13/1984SE |
| K800963 | Biopsy Forceps W/Needle M.R. Assoc.FCL · Traditional | Mr Associates, Inc. | 05/08/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2840-2026 Class II | Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4…Potential for breach in sterile barrier of device packaging. | Boston Scientific Corporation | 06/30/2026Open, Classified |
| Z-2839-2026 Class II | Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1.…Potential for breach in sterile barrier of device packaging. | Boston Scientific Corporation | 06/30/2026Open, Classified |
| Z-2838-2026 Class II | Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN:…Potential for breach in sterile barrier of device packaging. | Boston Scientific Corporation | 06/30/2026Open, Classified |
| Z-1425-2023 Class II | FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in… | Richard Wolf GmbH | 03/24/2023Open, Classified |
| Z-1424-2023 Class II | FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in… | Richard Wolf GmbH | 03/24/2023Open, Classified |
| Z-1423-2023 Class II | FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in… | Richard Wolf GmbH | 03/24/2023Open, Classified |
| Z-1422-2023 Class II | FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in… | Richard Wolf GmbH | 03/24/2023Open, Classified |
| Z-2622-2016 Class II | Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for…Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.… | Cook Inc. | 04/15/2016Terminated |
| Z-1774-2010 | Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps UPN/Catalog…Clevis may detach from the coil preventing the device to open and/or close. Delays in the procedure may… | Boston Scientific Corporation | 05/06/2010Terminated |
| Z-1773-2010 | Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps Box 80, 240cm…Clevis may detach from the coil preventing the device to open and/or close. Delays in the procedure may… | Boston Scientific Corporation | 05/06/2010Terminated |
| Z-1772-2010 | Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps Inner Pouch 240cm…Clevis may detach from the coil preventing the device to open and/or close. Delays in the procedure may… | Boston Scientific Corporation | 05/06/2010Terminated |