FDA 510(k) Application Details - K163675

Device Classification Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K163675
Device Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Applicant	FUJIFILM Medical System U.S.A., Inc. 10 High Point Drive Wayne, NJ 07470 US Other 510(k) Applications for this Company
Contact	Shraddha S More Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FET Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/27/2016
Decision Date	04/25/2017
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