Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KGE — Predicate Candidate Screening
46 FDA 510(k) clearances under this product code; the 50 most recent screened below.
125 daysmedian FDA review time
262 days90th percentile
46clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251807 | Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-4 | Olympus Medical Systems Corp. | 2026-03-06 | 267 | 0 |
| K250187 | Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biop | Olympus Medical Systems Corporation | 2025-10-07 | 258 | 0 |
| K242857 | ClearHemograsper | Finemedix Co., Ltd. | 2025-05-21 | 243 | 0 |
| K231721 | Disposable Hot Biopsy Forceps | Beijing Zksk Technology Co., Ltd. | 2023-12-14 | 184 | 0 |
| K220053 | Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI | Fujifilm Corporation | 2022-02-04 | 29 | 0 |
| K210406 | Bipolar Coagulation Foreceps | Hangzhou AGS MedTech Co., Ltd. | 2021-10-05 | 237 | 0 |
| K202438 | Ensure Single-Use Coagulation Forceps | Micro-Tech (Nanjing) Co., Ltd. | 2021-03-15 | 202 | 0 |
| K183428 | Avulsion Forceps | STERIS Corporation | 2019-04-16 | 126 | 0 |
| K180018 | Disposable Hot Biopsy Forceps | Micro-Tech (Nanjing) Co., Ltd. | 2018-07-05 | 184 | 0 |
| K180134 | Ensizor Monopolar Endoscopic Scissors | Slater Endoscopy, LLC | 2018-06-29 | 163 | 0 |
| K171973 | Captura® Disposable Hot Biopsy Forceps | Wilson-Cook Medical, Inc. | 2018-03-21 | 264 | 0 |
| K171916 | Single Use Hot Biopsy Forceps FD-231 | Olympus Medical Systems Corp. | 2017-10-13 | 109 | 0 |
| K171096 | Fujifilm Diathermic Slitter (FlushKnife) | Fujifilm Medical Systems U.S.A, Inc. | 2017-05-09 | 26 | 0 |
| K161186 | Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermi | Fujifilm Medical Systems U.S.A, Inc. | 2016-06-29 | 63 | 0 |
| K160625 | Disposable Hot Biopsy Forceps | Micro-Tech (Nanjing) Co., Ltd. | 2016-06-14 | 102 | 0 |
| K151474 | Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter | Fujifilm Medical System U.S.A., Inc. | 2016-02-18 | 262 | 0 |
| K141794 | ENDO-MARYLAND DISSECTOR | Ovesco Endoscopy AG | 2014-11-19 | 140 | 0 |
| K131991 | ENDOCHOICE HOT BIOPSY FORCEPS | Endochoice, Inc. | 2013-10-15 | 109 | 0 |
| K101657 | RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY F | Boston Scientific Corp | 2010-10-05 | 116 | 0 |
| K090796 | MULTI-BITE HOT BIOPSY FORCEPS | Endo-Therapeutics, Inc. | 2009-11-25 | 246 | 0 |
| K090583 | ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 | Apollo Endosurgery, Inc. | 2009-06-26 | 114 | 0 |
| K062517 | ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES | Olympus Medical Systems Corporation | 2006-12-22 | 116 | 0 |
| K022751 | REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS | Medical Device Services | 2002-11-04 | 77 | 0 |
| K022243 | HORIZONS REUSABLE HOT BIOPSY FORCEPS | Horizons Intl. Corp. | 2002-10-25 | 105 | 0 |
| K021706 | HORIZONS HOT BIOPSY FORCEPS | Horizons Intl. Corp. | 2002-06-21 | 29 | 0 |
| K000086 | WILSON-COOK REUSABLE HOT BIOPSY FORCEPS | Wilson-Cook Medical, Inc. | 2000-03-15 | 63 | 0 |
| K992390 | HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY | Telemed Systems, Inc. | 1999-12-22 | 156 | 0 |
| K990231 | WILTEK HOT BIOPSY FORCEPS | Wiltek Medical, Inc. | 1999-04-13 | 78 | 0 |
| K983811 | UNIPOLAR OPTICAL BIOPSY FORCEPS | Olympus Winter & Ibe GmbH | 1998-12-24 | 57 | 0 |
| K972505 | RESUABLE HOT BIOPSY FORCEPS | United States Endoscopy Group, Inc. | 1997-09-18 | 77 | 0 |
| K970083 | DYNABITE HOT GI BIOPSY FORCEPS | Portlyn Corp. | 1997-06-17 | 159 | 0 |
| K971204 | LSVP INTERNATIONAL HOT BIOPSY FORCEPS | Lsvp Intl., Inc. | 1997-05-27 | 56 | 0 |
| K953355 | GIP/MEID-GLOBE HOT BIOPSY FORCEPS | Medi-Globe Corp. | 1996-04-04 | 262 | 0 |
| K955052 | OLYMPUS FD-1/2-1 HOT BIOPSY FORCEPS | Olympus America, Inc. | 1996-01-24 | 79 | 0 |
| K951445 | OLYMPUS FD-5 HOT BIOPSY FORCEPS | Olympus America, Inc. | 1995-05-03 | 35 | 0 |
| K944765 | KARL STORZ INSULATED BIOPSY FORCEPS, GRASPING/DISSECTING FOR | KARL STORZ Endoscopy-America, Inc. | 1995-03-28 | 182 | 0 |
| K943078 | HOT BIOPSY FORCEPS | Intl. Medical, Inc. | 1994-11-14 | 139 | 0 |
| K940911 | BASICS ENDOSCOPY SYSTEM | Cox Medical Ent., Inc. | 1994-05-16 | 80 | 0 |
| K932266 | SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN | Symbiosis Corp. | 1994-03-15 | 329 | 0 |
| K932790 | THERMAL OPTION | Cox Medical Ent., Inc. | 1994-01-28 | 233 | 0 |
| K923470 | DISPOSABLE HOT BIOPSY FORCEPS | Wilson-Cook Medical, Inc. | 1993-04-21 | 281 | 0 |
| K925361 | BIOPSY FORCEPS, ELECTRIC | United States Endoscopy Group, Inc. | 1993-03-29 | 158 | 0 |
| K910964 | HOT BIOPSY FORCEPS | Symbiosis Corp. | 1991-05-02 | 57 | 0 |
| K905088 | HOT BIOPSY FORCEPS | Esco Precision, Inc. | 1991-03-19 | 125 | 0 |
| K904985 | BIPOLAR BIOPSY FORCEPS | Everest Medical Corp. | 1991-01-25 | 84 | 0 |
| K896537 | PORGES HOT BIOPSY FORCEPS | Porges Corp. | 1989-11-30 | 15 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda