FDA 510(k) Application Details - K162992

Device Classification Name	System, Irrigation, Urological   More FDA Info for this Device
510(K) Number	K162992
Device Name	System, Irrigation, Urological
Applicant	KARL STORZ ENDOSCOPY AMERICA, INC 2151 E. GRAND AVENUE EL SEGUNDO, CA 90245 US Other 510(k) Applications for this Company
Contact	SERKAN SEZER Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LJH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/27/2016
Decision Date	07/07/2017
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