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).
Recent Cleared Devices (20 of 46)
Showing 20 most recent of 46 cleared devices.
| 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 |
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
