FDA 510(k) Application Details - K161463

Device Classification Name	More FDA Info for this Device
510(K) Number	K161463
Device Name	SureClip(TM) Repositionable Hemostasis Clip
Applicant	Micro-Tech (Nanjing) CO., Ltd. NO. 10 Gaoke Third Road Nanjing 210032 CN Other 510(k) Applications for this Company
Contact	Becky Li 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	05/26/2016
Decision Date	01/06/2017
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