FDA 510(k) Application Details - K182444

Device Classification Name	Endoscopic Irrigation/Suction System   More FDA Info for this Device
510(K) Number	K182444
Device Name	Endoscopic Irrigation/Suction System
Applicant	Erbe USA, Inc. 2225 Northwest Parkway Marietta, GA 30067 US Other 510(k) Applications for this Company
Contact	John Tartal 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	09/07/2018
Decision Date	11/06/2018
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