510(k) K202438
- Device
- Ensure Single-Use Coagulation Forceps
- Applicant
- Micro-Tech (Nanjing) Co., Ltd.
- 510(k) number
- K202438
- Product code
- KGE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-03-15
- Date received
- 2020-08-25
- Regulation
- 876.4300
- Classification name
- Forceps, Biopsy, Electric
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Cecilia Sun
- Address
- # 10 Gaoke Thrid Rd. Nanjing CN 210032 210032
FDA Registration Numbers#
- 3014769442
- 3024021261
- 3007695959
- 3006546082
- 3013247477
- 3009888344
- 3011270181
- 3017616393
- 2528981
- 3004083736
- 3004837686
- 1223925
- 9614969
- 3010288205
- 1320894
- 1222168
- 3012042439
- 3008720584
- 9610773
- 3005099803
- 9610877
- 3004638277
- 3008386005
- 3042225166
- 1056129
- 3008040402
- 3007738736
- 1061927
- 3010707607
- 1037905
- 9614641
- 3011050570
- 8010047
- 3021632375
- 1000393132
- 9610617
- 3003782610
- 3010202439
- 3010273867
- 3014620201
- 9611680
- 1643817
- 3023102955
- 2020550
- 3014342096
- 1528319
- 3013440400
- 1319639
- 3013557562
- 3006161756
- 3015136743
- 3006696607
Source Documents#
Other 510(k) Records For Product Code KGE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251807 | Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR | Olympus Medical Systems Corp. | 2026-03-06 |
| K250187 | Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) | Olympus Medical Systems Corporation | 2025-10-07 |
| K242857 | ClearHemograsper | Finemedix Co., Ltd. | 2025-05-21 |
| K231721 | Disposable Hot Biopsy Forceps | Beijing Zksk Technology Co., Ltd. | 2023-12-14 |
| K220053 | Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI | Fujifilm Corporation | 2022-02-04 |
| K210406 | Bipolar Coagulation Foreceps | Hangzhou AGS MedTech Co., Ltd. | 2021-10-05 |
| K183428 | Avulsion Forceps | STERIS Corporation | 2019-04-16 |
| K180018 | Disposable Hot Biopsy Forceps | Micro-Tech (Nanjing) Co., Ltd. | 2018-07-05 |
| K180134 | Ensizor Monopolar Endoscopic Scissors | Slater Endoscopy, LLC | 2018-06-29 |
| K171973 | Captura® Disposable Hot Biopsy Forceps | Wilson-Cook Medical, Inc. | 2018-03-21 |
| K171916 | Single Use Hot Biopsy Forceps FD-231 | Olympus Medical Systems Corp. | 2017-10-13 |
| K171096 | Fujifilm Diathermic Slitter (FlushKnife) | Fujifilm Medical Systems U.S.A, Inc. | 2017-05-09 |
| K161186 | Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) | Fujifilm Medical Systems U.S.A, Inc. | 2016-06-29 |
| K160625 | Disposable Hot Biopsy Forceps | Micro-Tech (Nanjing) Co., Ltd. | 2016-06-14 |
| K151474 | Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) | Fujifilm Medical System U.S.A., Inc. | 2016-02-18 |
Legacy Summary#
summary
FDA Review#
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