KGE · Forceps, Biopsy, Electric
Gastroenterology, Urology · 21 CFR 876.4300 · Class 2
Overview
| Product Code | KGE |
|---|---|
| Device Name | Forceps, Biopsy, Electric |
| Regulation | 21 CFR 876.4300 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.
Classification Rationale
Class II (performance standards).
Cleared Devices (46)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251807 | Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR | Olympus Medical Systems Corp. | Mar 6, 2026 | SESE |
| K250187 | Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) | Olympus Medical Systems Corporation | Oct 7, 2025 | SESE |
| K242857 | ClearHemograsper | Finemedix Co., Ltd. | May 21, 2025 | SESE |
| K231721 | Disposable Hot Biopsy Forceps | Beijing Zksk Technology Co., Ltd. | Dec 14, 2023 | SESE |
| K220053 | Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI | Fujifilm Corporation | Feb 4, 2022 | SESE |
| K210406 | Bipolar Coagulation Foreceps | Hangzhou AGS MedTech Co., Ltd. | Oct 5, 2021 | SESE |
| K202438 | Ensure Single-Use Coagulation Forceps | Micro-Tech (Nanjing) Co., Ltd. | Mar 15, 2021 | SESE |
| K183428 | Avulsion Forceps | STERIS Corporation | Apr 16, 2019 | SESE |
| K180018 | Disposable Hot Biopsy Forceps | Micro-Tech (Nanjing) Co., Ltd. | Jul 5, 2018 | SESE |
| K180134 | Ensizor Monopolar Endoscopic Scissors | Slater Endoscopy, LLC | Jun 29, 2018 | SESE |
| K171973 | Captura® Disposable Hot Biopsy Forceps | Wilson-Cook Medical, Inc. | Mar 21, 2018 | SESE |
| K171916 | Single Use Hot Biopsy Forceps FD-231 | Olympus Medical Systems Corp. | Oct 13, 2017 | SESE |
| K171096 | Fujifilm Diathermic Slitter (FlushKnife) | Fujifilm Medical Systems U.S.A, Inc. | May 9, 2017 | SESE |
| K161186 | Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) | Fujifilm Medical Systems U.S.A, Inc. | Jun 29, 2016 | SESE |
| K160625 | Disposable Hot Biopsy Forceps | Micro-Tech (Nanjing) Co., Ltd. | Jun 14, 2016 | SESE |
| K151474 | Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) | Fujifilm Medical System U.S.A., Inc. | Feb 18, 2016 | SESE |
| K141794 | ENDO-MARYLAND DISSECTOR | Ovesco Endoscopy AG | Nov 19, 2014 | SESE |
| K131991 | ENDOCHOICE HOT BIOPSY FORCEPS | Endochoice, Inc. | Oct 15, 2013 | SESE |
| K101657 | RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40 | Boston Scientific Corp | Oct 5, 2010 | SESE |
| K090796 | MULTI-BITE HOT BIOPSY FORCEPS | Endo-Therapeutics, Inc. | Nov 25, 2009 | SESE |
| K090583 | ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 | Apollo Endosurgery, Inc. | Jun 26, 2009 | SESE |
| K062517 | ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES | Olympus Medical Systems Corporation | Dec 22, 2006 | SESE |
| K022751 | REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS | Medical Device Services | Nov 4, 2002 | SESE |
| K022243 | HORIZONS REUSABLE HOT BIOPSY FORCEPS | Horizons Intl. Corp. | Oct 25, 2002 | SESE |
| K021706 | HORIZONS HOT BIOPSY FORCEPS | Horizons Intl. Corp. | Jun 21, 2002 | SESE |
| K000086 | WILSON-COOK REUSABLE HOT BIOPSY FORCEPS | Wilson-Cook Medical, Inc. | Mar 15, 2000 | SESE |
| K992390 | HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD | Telemed Systems, Inc. | Dec 22, 1999 | SESE |
| K990231 | WILTEK HOT BIOPSY FORCEPS | Wiltek Medical, Inc. | Apr 13, 1999 | SESE |
| K983811 | UNIPOLAR OPTICAL BIOPSY FORCEPS | Olympus Winter & Ibe GmbH | Dec 24, 1998 | SESE |
| K972505 | RESUABLE HOT BIOPSY FORCEPS | United States Endoscopy Group, Inc. | Sep 18, 1997 | SESE |
| K970083 | DYNABITE HOT GI BIOPSY FORCEPS | Portlyn Corp. | Jun 17, 1997 | SESE |
| K971204 | LSVP INTERNATIONAL HOT BIOPSY FORCEPS | Lsvp Intl., Inc. | May 27, 1997 | SESE |
| K953355 | GIP/MEID-GLOBE HOT BIOPSY FORCEPS | Medi-Globe Corp. | Apr 4, 1996 | SESE |
| K955052 | OLYMPUS FD-1/2-1 HOT BIOPSY FORCEPS | Olympus America, Inc. | Jan 24, 1996 | SESE |
| K951445 | OLYMPUS FD-5 HOT BIOPSY FORCEPS | Olympus America, Inc. | May 3, 1995 | SESE |
| K944765 | KARL STORZ INSULATED BIOPSY FORCEPS, GRASPING/DISSECTING FORECPS, FLEXIBLE FORCEPS | KARL STORZ Endoscopy-America, Inc. | Mar 28, 1995 | SESE |
| K943078 | HOT BIOPSY FORCEPS | Intl. Medical, Inc. | Nov 14, 1994 | SESE |
| K940911 | BASICS ENDOSCOPY SYSTEM | Cox Medical Ent., Inc. | May 16, 1994 | SESE |
| K932266 | SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN | Symbiosis Corp. | Mar 15, 1994 | SESE |
| K932790 | THERMAL OPTION | Cox Medical Ent., Inc. | Jan 28, 1994 | SESE |
| K923470 | DISPOSABLE HOT BIOPSY FORCEPS | Wilson-Cook Medical, Inc. | Apr 21, 1993 | SESE |
| K925361 | BIOPSY FORCEPS, ELECTRIC | United States Endoscopy Group, Inc. | Mar 29, 1993 | SESE |
| K910964 | HOT BIOPSY FORCEPS | Symbiosis Corp. | May 2, 1991 | SESE |
| K905088 | HOT BIOPSY FORCEPS | Esco Precision, Inc. | Mar 19, 1991 | SESE |
| K904985 | BIPOLAR BIOPSY FORCEPS | Everest Medical Corp. | Jan 25, 1991 | SESE |
| K896537 | PORGES HOT BIOPSY FORCEPS | Porges Corp. | Nov 30, 1989 | SESE |
Top Applicants
- Wilson-Cook Medical, Inc. — 3 clearances
- Micro-Tech (Nanjing) Co., Ltd. — 3 clearances
- United States Endoscopy Group, Inc. — 2 clearances
- Symbiosis Corp. — 2 clearances
- Olympus Medical Systems Corporation — 2 clearances
