510(k) K210406

Device
Bipolar Coagulation Foreceps
Applicant
Hangzhou AGS MedTech Co., Ltd.
510(k) number
K210406
Product code
KGE
Decision
Substantially Equivalent (SESE)
Decision date
2021-10-05
Date received
2021-02-10
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

Related Records

Applicant Contact

Contact
Yanping Fu
Address
Bldg. 5,Bldg. 6, #597 Kangxin Rd. Yuhang District Hangzhou CN 311106 311106

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code KGE

510(k)DeviceApplicantDecision date
K251807Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LROlympus Medical Systems Corp.2026-03-06
K250187Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)Olympus Medical Systems Corporation2025-10-07
K242857ClearHemograsperFinemedix Co., Ltd.2025-05-21
K231721Disposable Hot Biopsy ForcepsBeijing Zksk Technology Co., Ltd.2023-12-14
K220053Diathermic Slitter (FlushKnife) DK2620JI and DK2623JIFujifilm Corporation2022-02-04
K202438Ensure Single-Use Coagulation ForcepsMicro-Tech (Nanjing) Co., Ltd.2021-03-15
K183428Avulsion ForcepsSTERIS Corporation2019-04-16
K180018Disposable Hot Biopsy ForcepsMicro-Tech (Nanjing) Co., Ltd.2018-07-05
K180134Ensizor Monopolar Endoscopic ScissorsSlater Endoscopy, LLC2018-06-29
K171973Captura® Disposable Hot Biopsy ForcepsWilson-Cook Medical, Inc.2018-03-21
K171916Single Use Hot Biopsy Forceps FD-231Olympus Medical Systems Corp.2017-10-13
K171096Fujifilm Diathermic Slitter (FlushKnife)Fujifilm Medical Systems U.S.A, Inc.2017-05-09
K161186Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)Fujifilm Medical Systems U.S.A, Inc.2016-06-29
K160625Disposable Hot Biopsy ForcepsMicro-Tech (Nanjing) Co., Ltd.2016-06-14
K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)Fujifilm Medical System U.S.A., Inc.2016-02-18