FDA 510(k) Application Details - K191254

Device Classification Name	More FDA Info for this Device
510(K) Number	K191254
Device Name	EndoClot
Applicant	EndoClot Plus Co., Ltd. 101 Room, B8 Building, 218 Xinghu Street, Suzhou Industrial Park SuZhou 215000 CN Other 510(k) Applications for this Company
Contact	Hendry Zhang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/10/2019
Decision Date	01/30/2020
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