Product Code: KGE FDA class 2 21 CFR 876.4300

Forceps, Biopsy, Electric

Gastroenterology, Urology

Electric Biopsy Forceps are endoscopic instruments that combine mechanical grasping with electrosurgical energy to obtain tissue samples and simultaneously coagulate the biopsy site, used in urological or gastroenterological endoscopic procedures to minimize bleeding during tissue sampling. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KGE, regulated under 21 CFR 876.4300, within the Gastroenterology, Urology medical specialty. This device is eligible for third-party review.

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FEI Numbers

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Basic Information

Product Code: KGE
Device Class: FDA class 2
Regulation Number: 876.4300
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 46 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251807	Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR	Mar 06, 2026	Substantially Equivalent	Olympus Medical Systems Corp.
K250187	Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)	Oct 07, 2025	Substantially Equivalent	Olympus Medical Systems Corporation
K242857	ClearHemograsper	May 21, 2025	Substantially Equivalent	Finemedix Co., Ltd.
K231721	Disposable Hot Biopsy Forceps	Dec 14, 2023	Substantially Equivalent	Beijing Zksk Technology Co., Ltd.
K220053	Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI	Feb 04, 2022	Substantially Equivalent	Fujifilm Corporation
K210406	Bipolar Coagulation Foreceps	Oct 05, 2021	Substantially Equivalent	Hangzhou AGS MedTech Co., Ltd.
K202438	Ensure Single-Use Coagulation Forceps	Mar 15, 2021	Substantially Equivalent	Micro-Tech (Nanjing) Co., Ltd.
K183428	Avulsion Forceps	Apr 16, 2019	Substantially Equivalent	STERIS Corporation
K180018	Disposable Hot Biopsy Forceps	Jul 05, 2018	Substantially Equivalent	Micro-Tech (Nanjing) Co., Ltd.
K180134	Ensizor Monopolar Endoscopic Scissors	Jun 29, 2018	Substantially Equivalent	Slater Endoscopy, LLC
K171973	Captura® Disposable Hot Biopsy Forceps	Mar 21, 2018	Substantially Equivalent	Wilson-Cook Medical, Inc.
K171916	Single Use Hot Biopsy Forceps FD-231	Oct 13, 2017	Substantially Equivalent	Olympus Medical Systems Corp.
K171096	Fujifilm Diathermic Slitter (FlushKnife)	May 09, 2017	Substantially Equivalent	Fujifilm Medical Systems U.S.A, Inc.
K161186	Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)	Jun 29, 2016	Substantially Equivalent	Fujifilm Medical Systems U.S.A, Inc.
K160625	Disposable Hot Biopsy Forceps	Jun 14, 2016	Substantially Equivalent	Micro-Tech (Nanjing) Co., Ltd.
K151474	Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)	Feb 18, 2016	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K141794	ENDO-MARYLAND DISSECTOR	Nov 19, 2014	Substantially Equivalent	Ovesco Endoscopy AG
K131991	ENDOCHOICE HOT BIOPSY FORCEPS	Oct 15, 2013	Substantially Equivalent	Endochoice, Inc.
K101657	RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40	Oct 05, 2010	Substantially Equivalent	Boston Scientific Corp
K090796	MULTI-BITE HOT BIOPSY FORCEPS	Nov 25, 2009	Substantially Equivalent	Endo-Therapeutics, Inc.
K090583	ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165	Jun 26, 2009	Substantially Equivalent	Apollo Endosurgery, Inc.
K062517	ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES	Dec 22, 2006	Substantially Equivalent	Olympus Medical Systems Corporation
K022751	REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS	Nov 04, 2002	Substantially Equivalent	Medical Device Services
K022243	HORIZONS REUSABLE HOT BIOPSY FORCEPS	Oct 25, 2002	Substantially Equivalent	Horizons Intl. Corp.
K021706	HORIZONS HOT BIOPSY FORCEPS	Jun 21, 2002	Substantially Equivalent	Horizons Intl. Corp.
K000086	WILSON-COOK REUSABLE HOT BIOPSY FORCEPS	Mar 15, 2000	Substantially Equivalent	Wilson-Cook Medical, Inc.
K992390	HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD	Dec 22, 1999	Substantially Equivalent	Telemed Systems, Inc.
K990231	WILTEK HOT BIOPSY FORCEPS	Apr 13, 1999	Substantially Equivalent	Wiltek Medical, Inc.
K983811	UNIPOLAR OPTICAL BIOPSY FORCEPS	Dec 24, 1998	Substantially Equivalent	Olympus Winter & Ibe GmbH
K972505	RESUABLE HOT BIOPSY FORCEPS	Sep 18, 1997	Substantially Equivalent	United States Endoscopy Group, Inc.
K970083	DYNABITE HOT GI BIOPSY FORCEPS	Jun 17, 1997	Substantially Equivalent	Portlyn Corp.
K971204	LSVP INTERNATIONAL HOT BIOPSY FORCEPS	May 27, 1997	Substantially Equivalent	Lsvp Intl., Inc.
K953355	GIP/MEID-GLOBE HOT BIOPSY FORCEPS	Apr 04, 1996	Substantially Equivalent	Medi-Globe Corp.
K955052	OLYMPUS FD-1/2-1 HOT BIOPSY FORCEPS	Jan 24, 1996	Substantially Equivalent	Olympus America, Inc.
K951445	OLYMPUS FD-5 HOT BIOPSY FORCEPS	May 03, 1995	Substantially Equivalent	Olympus America, Inc.
K944765	KARL STORZ INSULATED BIOPSY FORCEPS, GRASPING/DISSECTING FORECPS, FLEXIBLE FORCEPS	Mar 28, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K943078	HOT BIOPSY FORCEPS	Nov 14, 1994	Substantially Equivalent	Intl. Medical, Inc.
K940911	BASICS ENDOSCOPY SYSTEM	May 16, 1994	Substantially Equivalent	Cox Medical Ent., Inc.
K932266	SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN	Mar 15, 1994	Substantially Equivalent	Symbiosis Corp.
K932790	THERMAL OPTION	Jan 28, 1994	Substantially Equivalent	Cox Medical Ent., Inc.
K923470	DISPOSABLE HOT BIOPSY FORCEPS	Apr 21, 1993	Substantially Equivalent	Wilson-Cook Medical, Inc.
K925361	BIOPSY FORCEPS, ELECTRIC	Mar 29, 1993	Substantially Equivalent	United States Endoscopy Group, Inc.
K910964	HOT BIOPSY FORCEPS	May 02, 1991	Substantially Equivalent	Symbiosis Corp.
K905088	HOT BIOPSY FORCEPS	Mar 19, 1991	Substantially Equivalent	Esco Precision, Inc.
K904985	BIPOLAR BIOPSY FORCEPS	Jan 25, 1991	Substantially Equivalent	Everest Medical Corp.
K896537	PORGES HOT BIOPSY FORCEPS	Nov 30, 1989	Substantially Equivalent	Porges Corp.