FDA 510(k) Application Details - K152583

Device Classification Name	More FDA Info for this Device
510(K) Number	K152583
Device Name	KARL STORZ Endoscopic ICG Imaging System
Applicant	KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVENUE EL SEGUNDO, CA 90245 US Other 510(k) Applications for this Company
Contact	Mike Samuels Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/10/2015
Decision Date	05/31/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review