FDA 510(k) Application Details - K172575

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K172575
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	BAROnova, Inc. 1509 Industrial Road San Carlos, CA 94070 US Other 510(k) Applications for this Company
Contact	Lian Cunningham Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/2017
Decision Date	01/18/2018
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