FDA 510(k) Application Details - K161147

Device Classification Name	Choledochoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K161147
Device Name	Choledochoscope And Accessories, Flexible/Rigid
Applicant	ENDOCURE TECHNOLOGIES, INC. 5801 AMMENDALE ROAD, SUITE A BELTSVILLE, MD 20705 US Other 510(k) Applications for this Company
Contact	CHARLES J. NEFF Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FBN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2016
Decision Date	06/07/2016
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