FDA 510(k) Application Details - K172666

Device Classification Name	Endoscopic Tissue Approximation Device   More FDA Info for this Device
510(K) Number	K172666
Device Name	Endoscopic Tissue Approximation Device
Applicant	SutureEase, Inc. 1735 N First Street, Suite 300 San Jose, CA 95112 US Other 510(k) Applications for this Company
Contact	Scott Heneveld Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	OCW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/05/2017
Decision Date	12/01/2017
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