FDA 510(k) Application Details - K212669

Device Classification Name	More FDA Info for this Device
510(K) Number	K212669
Device Name	Single Use Hemoclip
Applicant	Zhejiang Chuangxiang Medical Technology Co., LTD. 301B, No.22, XinYan Road, Yuhang District Hangzhou 311100 CN Other 510(k) Applications for this Company
Contact	Lucius Long 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	08/23/2021
Decision Date	05/27/2022
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