FDA 510(k) Application Details - K201771

Device Classification Name	More FDA Info for this Device
510(K) Number	K201771
Device Name	Single Use Rotatable and Repositionable Hemoclip
Applicant	Anrei Medical (Hangzhou) Co., Ltd. No.3 Ave. 8, Hangzhou Economic Development Area Hangzhou 310018 CN Other 510(k) Applications for this Company
Contact	Huibing Yang 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	06/29/2020
Decision Date	10/19/2020
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