FDA 510(k) Application Details - K183309

Device Classification Name	More FDA Info for this Device
510(K) Number	K183309
Device Name	stentfix OTSC System Set
Applicant	Ovesco Endoscopy AG Dorfackerstrasse 26 Tuebingen 72074 DE Other 510(k) Applications for this Company
Contact	Marc O. Schurr 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	11/29/2018
Decision Date	10/22/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review