FDA 510(k) Application Details - K193036

Device Classification Name	Endoscopic Irrigation/Suction System   More FDA Info for this Device
510(K) Number	K193036
Device Name	Endoscopic Irrigation/Suction System
Applicant	PENTAX Medical, A Division of PENTAX of America, Inc. 303 Convention Way, Suite 1 Redwood City, CA 94063 US Other 510(k) Applications for this Company
Contact	Gurvinder Singh Nanda 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	10/31/2019
Decision Date	11/22/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review