FDA 510(k) Application Details - K160275

Device Classification Name	More FDA Info for this Device
510(K) Number	K160275
Device Name	Fuse Endoscopic System with FuseBox Processor
Applicant	EndoChoice Inc. 11810 Wills Rd Alpharetta, GA 30009 US Other 510(k) Applications for this Company
Contact	Daniel Hoefer Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/02/2016
Decision Date	08/01/2016
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