FDA.reportPublic FDA data

510(k) K231721

Device
Disposable Hot Biopsy Forceps
Applicant
Beijing Zksk Technology Co., Ltd.
510(k) number
K231721
Product code
KGE
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-14
Date received
2023-06-13
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
Ma Li
Address
Bldg. 9, 6 & #6 Yuan Hengye N. 7th St., Yongle Economic Development Zone, Tongzho Beijing CN 101105 101105

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KGE#

510(k), Device, Applicant table
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
K220053Diathermic Slitter (FlushKnife) DK2620JI and DK2623JIFujifilm Corporation2022-02-04
K210406Bipolar Coagulation ForecepsHangzhou AGS MedTech Co., Ltd.2021-10-05
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