FDA 510(k) Application Details - K211787

Device Classification Name	More FDA Info for this Device
510(K) Number	K211787
Device Name	Hemoclip
Applicant	Hangzhou AGS MedTech Co., Ltd. Building 5, Building 6, No. 597 Kangxin Road Yuhang District Hangzhou 311106 CN Other 510(k) Applications for this Company
Contact	Yanping Fu Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/09/2021
Decision Date	03/03/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review