FDA 510(k) Application Details - K160356

Device Classification Name	Colonoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K160356
Device Name	Colonoscope And Accessories, Flexible/Rigid
Applicant	AVANTIS MEDICAL SYSTEMS, INC. 2367 BERING DRIVE San Jose, CA 95131 US Other 510(k) Applications for this Company
Contact	Louis Fries Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FDF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/2016
Decision Date	05/17/2016
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