FDA 510(k) Applications for Medical Device Product Code "KGE"
(Forceps, Biopsy, Electric)

FDA 510(k) Number Applicant Device Name Decision Date
K090583 APOLLO ENDOSURGERY, INC. ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 06/26/2009
K101657 BOSTON SCIENTIFIC CORP. RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40 10/05/2010
K090796 ENDO-THERAPEUTICS, INC. MULTI-BITE HOT BIOPSY FORCEPS 11/25/2009
K131991 ENDOCHOICE, INC. ENDOCHOICE HOT BIOPSY FORCEPS 10/15/2013
K220053 FUJIFILM Corporation Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI 02/04/2022
K151474 FUJIFILM MEDICAL SYSTEM U.S.A., INC. Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) 02/18/2016
K171096 FUJIFILM Medical Systems U.S.A., Inc. Fujifilm Diathermic Slitter (FlushKnife) 05/09/2017
K161186 FUJIFILM MEDICAL SYSTEMS U.S.A., INC. Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) 06/29/2016
K210406 Hangzhou AGS MedTech Co., Ltd. Bipolar Coagulation Foreceps 10/05/2021
K021706 HORIZONS INTL. CORP. HORIZONS HOT BIOPSY FORCEPS 06/21/2002
K022243 HORIZONS INTL. CORP. HORIZONS REUSABLE HOT BIOPSY FORCEPS 10/25/2002
K971204 LSVP INTL., INC. LSVP INTERNATIONAL HOT BIOPSY FORCEPS 05/27/1997
K953355 MEDI-GLOBE CORP. GIP/MEID-GLOBE HOT BIOPSY FORCEPS 04/04/1996
K022751 MEDICAL DEVICE SERVICES REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS 11/04/2002
K160625 MICRO-TECH (NANJING) CO., LTD. Disposable Hot Biopsy Forceps 06/14/2016
K180018 Micro-Tech (Nanjing) CO., Ltd. Disposable Hot Biopsy Forceps 07/05/2018
K202438 Micro-Tech (Nanjing) Co., Ltd. Ensure Single-Use Coagulation Forceps 03/15/2021
K955052 OLYMPUS AMERICA, INC. OLYMPUS FD-1/2-1 HOT BIOPSY FORCEPS 01/24/1996
K171916 Olympus Medical Systems Corp. Single Use Hot Biopsy Forceps FD-231 10/13/2017
K062517 OLYMPUS MEDICAL SYSTEMS CORPORATION ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES 12/22/2006
K983811 OLYMPUS WINTER & IBE GMBH UNIPOLAR OPTICAL BIOPSY FORCEPS 12/24/1998
K141794 OVESCO ENDOSCOPY AG ENDO-MARYLAND DISSECTOR 11/19/2014
K970083 PORTLYN CORP. DYNABITE HOT GI BIOPSY FORCEPS 06/17/1997
K180134 Slater Endoscopy, LLC Ensizor Monopolar Endoscopic Scissors 06/29/2018
K183428 STERIS Corporation Avulsion Forceps 04/16/2019
K992390 TELEMED SYSTEMS, INC. HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD 12/22/1999
K972505 UNITED STATES ENDOSCOPY GROUP, INC. RESUABLE HOT BIOPSY FORCEPS 09/18/1997
K171973 Wilson-Cook Medical, Inc. Captura« Disposable Hot Biopsy Forceps 03/21/2018
K000086 WILSON-COOK MEDICAL, INC. WILSON-COOK REUSABLE HOT BIOPSY FORCEPS 03/15/2000
K990231 WILTEK MEDICAL, INC. WILTEK HOT BIOPSY FORCEPS 04/13/1999


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