Atlas FDA

KGE

46 FDA 510(k) clearances · Product code

125 daysmedian time to decision
262 days90th percentile
46clearances measured

FDA profile

Official device name
Forceps, Biopsy, Electric
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4300
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
Adverse events (MAUDE)
2016: 9 · 2017: 26 · 2018: 26 · 2019: 15 · 2021: 24 · 2022: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR (K251807)Olympus Medical Systems Corp.2026-03-06
Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) (K250187)Olympus Medical Systems Corporation2025-10-07
ClearHemograsper (K242857)Finemedix Co., Ltd.2025-05-21
Disposable Hot Biopsy Forceps (K231721)Beijing Zksk Technology Co., Ltd.2023-12-14
Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI (K220053)Fujifilm Corporation2022-02-04
Bipolar Coagulation Foreceps (K210406)Hangzhou AGS MedTech Co., Ltd.2021-10-05
Ensure Single-Use Coagulation Forceps (K202438)Micro-Tech (Nanjing) Co., Ltd.2021-03-15
Avulsion Forceps (K183428)STERIS Corporation2019-04-16
Disposable Hot Biopsy Forceps (K180018)Micro-Tech (Nanjing) Co., Ltd.2018-07-05
Ensizor Monopolar Endoscopic Scissors (K180134)Slater Endoscopy, LLC2018-06-29
Captura® Disposable Hot Biopsy Forceps (K171973)Wilson-Cook Medical, Inc.2018-03-21
Single Use Hot Biopsy Forceps FD-231 (K171916)Olympus Medical Systems Corp.2017-10-13
Fujifilm Diathermic Slitter (FlushKnife) (K171096)Fujifilm Medical Systems U.S.A, Inc.2017-05-09
Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) (K161186)Fujifilm Medical Systems U.S.A, Inc.2016-06-29
Disposable Hot Biopsy Forceps (K160625)Micro-Tech (Nanjing) Co., Ltd.2016-06-14
Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) (K151474)Fujifilm Medical System U.S.A., Inc.2016-02-18
ENDO-MARYLAND DISSECTOR (K141794)Ovesco Endoscopy AG2014-11-19
ENDOCHOICE HOT BIOPSY FORCEPS (K131991)Endochoice, Inc.2013-10-15
RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40 (K101657)Boston Scientific Corp2010-10-05
MULTI-BITE HOT BIOPSY FORCEPS (K090796)Endo-Therapeutics, Inc.2009-11-25
ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 (K090583)Apollo Endosurgery, Inc.2009-06-26
ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES (K062517)Olympus Medical Systems Corporation2006-12-22
REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS (K022751)Medical Device Services2002-11-04
HORIZONS REUSABLE HOT BIOPSY FORCEPS (K022243)Horizons Intl. Corp.2002-10-25
HORIZONS HOT BIOPSY FORCEPS (K021706)Horizons Intl. Corp.2002-06-21
WILSON-COOK REUSABLE HOT BIOPSY FORCEPS (K000086)Wilson-Cook Medical, Inc.2000-03-15
HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD (K992390)Telemed Systems, Inc.1999-12-22
WILTEK HOT BIOPSY FORCEPS (K990231)Wiltek Medical, Inc.1999-04-13
UNIPOLAR OPTICAL BIOPSY FORCEPS (K983811)Olympus Winter & Ibe GmbH1998-12-24
RESUABLE HOT BIOPSY FORCEPS (K972505)United States Endoscopy Group, Inc.1997-09-18
DYNABITE HOT GI BIOPSY FORCEPS (K970083)Portlyn Corp.1997-06-17
LSVP INTERNATIONAL HOT BIOPSY FORCEPS (K971204)Lsvp Intl., Inc.1997-05-27
GIP/MEID-GLOBE HOT BIOPSY FORCEPS (K953355)Medi-Globe Corp.1996-04-04
OLYMPUS FD-1/2-1 HOT BIOPSY FORCEPS (K955052)Olympus America, Inc.1996-01-24
OLYMPUS FD-5 HOT BIOPSY FORCEPS (K951445)Olympus America, Inc.1995-05-03
KARL STORZ INSULATED BIOPSY FORCEPS, GRASPING/DISSECTING FORECPS, FLEXIBLE FORCEPS (K944765)KARL STORZ Endoscopy-America, Inc.1995-03-28
HOT BIOPSY FORCEPS (K943078)Intl. Medical, Inc.1994-11-14
BASICS ENDOSCOPY SYSTEM (K940911)Cox Medical Ent., Inc.1994-05-16
SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN (K932266)Symbiosis Corp.1994-03-15
THERMAL OPTION (K932790)Cox Medical Ent., Inc.1994-01-28
DISPOSABLE HOT BIOPSY FORCEPS (K923470)Wilson-Cook Medical, Inc.1993-04-21
BIOPSY FORCEPS, ELECTRIC (K925361)United States Endoscopy Group, Inc.1993-03-29
HOT BIOPSY FORCEPS (K910964)Symbiosis Corp.1991-05-02
HOT BIOPSY FORCEPS (K905088)Esco Precision, Inc.1991-03-19
BIPOLAR BIOPSY FORCEPS (K904985)Everest Medical Corp.1991-01-25
PORGES HOT BIOPSY FORCEPS (K896537)Porges Corp.1989-11-30

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Every clearance here is in the API, with alerts when new ones post.