KGE · Class II · 21 CFR 876.4300

FDA Product Code KGE: Forceps, Biopsy, Electric

Electrosurgical biopsy forceps combine tissue sampling with hemostasis in a single instrument. FDA product code KGE covers electric biopsy forceps used during gastrointestinal endoscopy.

These forceps apply electrical current to coagulate the tissue before or after biopsy, reducing bleeding risk in highly vascular lesions. They are used for polyp sampling, tumor biopsy, and treatment of vascular lesions in the GI tract.

KGE devices are Class II medical devices, regulated under 21 CFR 876.4300 and reviewed by the FDA Gastroenterology & Urology panel.

Leading manufacturers include Wilson-Cook Medical, Inc., Micro-Tech (Nanjing) Co., Ltd. and United States Endoscopy Group, Inc..

46
Total
46
Cleared
141d
Avg days
1989
Since
Growing category - 3 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 256d recently vs 133d historically

FDA 510(k) Cleared Forceps, Biopsy, Electric Devices (Product Code KGE)

46 devices
1–24 of 46
Cleared Mar 06, 2026
Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR
K251807
Olympus Medical Systems Corp.
Gastroenterology & Urology · 267d
Cleared Oct 07, 2025
Disposable Hot Biopsy Forceps (FD-210U)
K250187
Olympus Medical Systems Corporation
Gastroenterology & Urology · 258d
Cleared May 21, 2025
ClearHemograsper
K242857
Finemedix Co., Ltd.
Gastroenterology & Urology · 243d
Cleared Dec 14, 2023
Disposable Hot Biopsy Forceps
K231721
Beijing Zksk Technology Co., Ltd.
Gastroenterology & Urology · 184d
Cleared Feb 04, 2022
Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI
K220053
Fujifilm Corporation
Gastroenterology & Urology · 29d
Cleared Oct 05, 2021
Bipolar Coagulation Foreceps
K210406
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 237d
Cleared Mar 15, 2021
Ensure Single-Use Coagulation Forceps
K202438
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 202d
Cleared Apr 16, 2019
Avulsion Forceps
K183428
STERIS Corporation
Gastroenterology & Urology · 126d
Cleared Jul 05, 2018
Disposable Hot Biopsy Forceps
K180018
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 184d
Cleared Jun 29, 2018
Ensizor Monopolar Endoscopic Scissors
K180134
Slater Endoscopy, LLC
Gastroenterology & Urology · 163d
Cleared Mar 21, 2018
Captura® Disposable Hot Biopsy Forceps
K171973
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 264d
Cleared Oct 13, 2017
Single Use Hot Biopsy Forceps FD-231
K171916
Olympus Medical Systems Corp.
Gastroenterology & Urology · 109d
Cleared May 09, 2017
Fujifilm Diathermic Slitter (FlushKnife)
K171096
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 26d
Cleared Jun 29, 2016
Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)
K161186
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 63d
Cleared Jun 14, 2016
Disposable Hot Biopsy Forceps
K160625
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 102d
Cleared Feb 18, 2016
Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)
K151474
Fujifilm Medical System U.S.A., Inc.
Gastroenterology & Urology · 262d
Cleared Oct 05, 2010
RADIAL 4 HOT BIOPSY FORCEPS BOX 5
K101657
Boston Scientific Corp
Gastroenterology & Urology · 116d
Cleared Dec 22, 2006
ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES
K062517
Olympus Medical Systems Corporation
Gastroenterology & Urology · 116d
Cleared Mar 15, 2000
WILSON-COOK REUSABLE HOT BIOPSY FORCEPS
K000086
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 63d
Cleared Dec 24, 1998
UNIPOLAR OPTICAL BIOPSY FORCEPS
K983811
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 57d
Cleared Sep 18, 1997
RESUABLE HOT BIOPSY FORCEPS
K972505
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 77d
Cleared Jan 24, 1996
OLYMPUS FD-1/2-1 HOT BIOPSY FORCEPS
K955052
Olympus America, Inc.
Gastroenterology & Urology · 79d
Cleared May 03, 1995
OLYMPUS FD-5 HOT BIOPSY FORCEPS
K951445
Olympus America, Inc.
Gastroenterology & Urology · 35d
Cleared Mar 28, 1995
KARL STORZ INSULATED BIOPSY FORCEPS, GRASPING/DISSECTING FORECPS, FLEXIBLE FORCEPS
K944765
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 182d

About Product Code KGE - Regulatory Context

510(k) Submission Activity

46 total 510(k) submissions under product code KGE since 1989, with 46 receiving FDA clearance (average review time: 141 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - KGE Product Code

Recent submissions under KGE have taken an average of 256 days to reach a decision - up from 133 days historically. Manufacturers should account for longer review timelines in current project planning.

KGE devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →