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

Related Records

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

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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