FDA 510(k) Application Details - K171637

Device Classification Name	Endoscopic Irrigation/Suction System   More FDA Info for this Device
510(K) Number	K171637
Device Name	Endoscopic Irrigation/Suction System
Applicant	Cipher Surgical Ltd The Venture Centre, Sir William Lyons Road Coventry CV4 7EZ GB Other 510(k) Applications for this Company
Contact	Justin Buch Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	OCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/2017
Decision Date	02/26/2018
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