FDA 510(k) Application Details - K183595

Device Classification Name	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)   More FDA Info for this Device
510(K) Number	K183595
Device Name	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant	Aqua Medical, Inc. 191 West Second St. Santa Ana, CA 92701 US Other 510(k) Applications for this Company
Contact	Lloyd Mencinger Other 510(k) Applications for this Contact
Regulation Number	876.4300   More FDA Info for this Regulation Number
Classification Product Code	KNS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2018
Decision Date	06/21/2019
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