Forceps, Biopsy, Electric
FDA product code KGE · Class II (moderate risk) · 21 CFR 876.4300 · Gastroenterology, Urology
46510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Olympus Medical Systems Corp. 4
- Micro-Tech (Nanjing) Co., Ltd. 3
- Wilson-Cook Medical, Inc. 3
- Fujifilm Medical Systems U.S.A, Inc. 2
- Symbiosis Corp. 2
- United States Endoscopy Group, Inc. 2
- Cox Medical Ent., Inc. 2
- Olympus America, Inc. 2
- Horizons Intl. Corp. 2
- Medi-Globe Corp. 1
- Medical Device Services 1
- Telemed Systems, Inc. 1
- Finemedix Co., Ltd. 1
- Olympus Winter & Ibe GmbH 1
- Portlyn Corp. 1
- Lsvp Intl., Inc. 1
- Porges Corp. 1
- KARL STORZ Endoscopy-America, Inc. 1
- Intl. Medical, Inc. 1
- Esco Precision, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251807 | Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LRKGE · Traditional | Olympus Medical Systems Corp. | 03/06/2026SE |
| K250187 | Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)KGE · Traditional | Olympus Medical Systems Corporation | 10/07/2025SE |
| K242857 | ClearHemograsperKGE · Traditional | Finemedix Co., Ltd. | 05/21/2025SE |
| K231721 | Disposable Hot Biopsy ForcepsKGE · Traditional | Beijing Zksk Technology Co., Ltd. | 12/14/2023SE |
| K220053 | Diathermic Slitter (FlushKnife) DK2620JI and DK2623JIKGE · Special | Fujifilm Corporation | 02/04/2022SE |
| K210406 | Bipolar Coagulation ForecepsKGE · Traditional | Hangzhou AGS MedTech Co., Ltd. | 10/05/2021SE |
| K202438 | Ensure Single-Use Coagulation ForcepsKGE · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 03/15/2021SE |
| K183428 | Avulsion ForcepsKGE · Traditional | STERIS Corporation | 04/16/2019SE |
| K180018 | Disposable Hot Biopsy ForcepsKGE · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 07/05/2018SE |
| K180134 | Ensizor Monopolar Endoscopic ScissorsKGE · Traditional | Slater Endoscopy, LLC | 06/29/2018SE |
| K171973 | Captura® Disposable Hot Biopsy ForcepsKGE · Traditional | Wilson-Cook Medical, Inc. | 03/21/2018SE |
| K171916 | Single Use Hot Biopsy Forceps FD-231KGE · Traditional | Olympus Medical Systems Corp. | 10/13/2017SE |
| K171096 | Fujifilm Diathermic Slitter (FlushKnife)KGE · Special | Fujifilm Medical Systems U.S.A, Inc. | 05/09/2017SE |
| K161186 | Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)KGE · Special | Fujifilm Medical Systems U.S.A, Inc. | 06/29/2016SE |
| K160625 | Disposable Hot Biopsy ForcepsKGE · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 06/14/2016SE |
| K151474 | Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)KGE · Traditional | Fujifilm Medical System U.S.A., Inc. | 02/18/2016SE |
| K141794 | Endo-Maryland DissectorKGE · Traditional | Ovesco Endoscopy AG | 11/19/2014SE |
| K131991 | Endochoice Hot Biopsy ForcepsKGE · Traditional | Endochoice, Inc. | 10/15/2013SE |
| K101657 | Radial 4 Hot Biopsy Forceps Box 5; Radial Jaw 4 Hot Biopsy Forceps Box 20; Radial Jaw 4…KGE · Abbreviated | Boston Scientific Corp | 10/05/2010SE |
| K090796 | Multi-Bite Hot Biopsy ForcepsKGE · Traditional | Endo-Therapeutics, Inc. | 11/25/2009SE |
| K090583 | Endoscopic Monopolar Scissors, Models EMS-235, EMS-165KGE · Traditional | Apollo Endosurgery, Inc. | 06/26/2009SE |
| K062517 | Electrosurgical Hemostatic Forceps SeriesKGE · Traditional | Olympus Medical Systems Corporation | 12/22/2006SE |
| K022751 | Reprocessed Used Disposable Hot and Cold Biopsy ForcepsKGE · Traditional | Medical Device Services | 11/04/2002SE |
| K022243 | Horizons Reusable Hot Biopsy ForcepsKGE · Traditional | Horizons Intl. Corp. | 10/25/2002SE |
| K021706 | Horizons Hot Biopsy ForcepsKGE · Traditional | Horizons Intl. Corp. | 06/21/2002SE |
| K000086 | Wilson-Cook Reusable Hot Biopsy ForcepsKGE · Traditional | Wilson-Cook Medical, Inc. | 03/15/2000SE |
| K992390 | Hot Biopsy Forceps Feenestrated 230 CM Oval Cup, Hot Biopsy Forceps Serrated 160 CM Oval…KGE · Traditional | Telemed Systems, Inc. | 12/22/1999SE |
| K990231 | Wiltek Hot Biopsy ForcepsKGE · Traditional | Wiltek Medical, Inc. | 04/13/1999SE |
| K983811 | Unipolar Optical Biopsy ForcepsKGE · Traditional | Olympus Winter & Ibe GmbH | 12/24/1998SE |
| K972505 | Resuable Hot Biopsy ForcepsKGE · Traditional | United States Endoscopy Group, Inc. | 09/18/1997SE |
| K970083 | Dynabite Hot Gi Biopsy ForcepsKGE · Traditional | Portlyn Corp. | 06/17/1997SE |
| K971204 | LSVP International Hot Biopsy ForcepsKGE · Traditional | Lsvp Intl., Inc. | 05/27/1997SE |
| K953355 | Gip/Meid-Globe Hot Biopsy ForcepsKGE · Traditional | Medi-Globe Corp. | 04/04/1996SE |
| K955052 | Olympus FD-1/2-1 Hot Biopsy ForcepsKGE · Traditional | Olympus America, Inc. | 01/24/1996SE |
| K951445 | Olympus FD-5 Hot Biopsy ForcepsKGE · Traditional | Olympus America, Inc. | 05/03/1995SE |
| K944765 | Karl Storz Insulated Biopsy Forceps, Grasping/Dissecting Forecps, Flexible ForcepsKGE · Traditional | KARL STORZ Endoscopy-America, Inc. | 03/28/1995SE |
| K943078 | Hot Biopsy ForcepsKGE · Traditional | Intl. Medical, Inc. | 11/14/1994SE |
| K940911 | Basics Endoscopy SystemKGE · Traditional | Cox Medical Ent., Inc. | 05/16/1994SE |
| K932266 | Symbiosis Dispos Gastro Biopsy Forceps W/Reuse HanKGE · Traditional | Symbiosis Corp. | 03/15/1994SE |
| K932790 | Thermal OptionKGE · Traditional | Cox Medical Ent., Inc. | 01/28/1994SE |
| K923470 | Disposable Hot Biopsy ForcepsKGE · Traditional | Wilson-Cook Medical, Inc. | 04/21/1993SE |
| K925361 | Biopsy Forceps, ElectricKGE · Traditional | United States Endoscopy Group, Inc. | 03/29/1993SE |
| K910964 | Hot Biopsy ForcepsKGE · Traditional | Symbiosis Corp. | 05/02/1991SE |
| K905088 | Hot Biopsy ForcepsKGE · Traditional | Esco Precision, Inc. | 03/19/1991SE |
| K904985 | Bipolar Biopsy ForcepsKGE · Traditional | Everest Medical Corp. | 01/25/1991SE |
| K896537 | Porges Hot Biopsy ForcepsKGE · Traditional | Porges Corp. | 11/30/1989SE |