FDA 510(k) Application Details - K242586

Device Classification Name	Endoscopic Irrigation/Suction System   More FDA Info for this Device
510(K) Number	K242586
Device Name	Endoscopic Irrigation/Suction System
Applicant	Ovesco Endoscopy AG Friedrich-Miescher-Strasse 9 Tuebingen 72076 DE Other 510(k) Applications for this Company
Contact	Clara Thiemann 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	08/30/2024
Decision Date	05/22/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review