FDA 510(k) Application Details - K241704

Device Classification Name	Endoscopic Irrigation/Suction System   More FDA Info for this Device
510(K) Number	K241704
Device Name	Endoscopic Irrigation/Suction System
Applicant	Hangzhou AGS MedTech Co., Ltd. Building 5,Building 6, No.597 Kangxin Road Yuhang District Hangzhou 311106 CN Other 510(k) Applications for this Company
Contact	Yanping Fu 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	06/13/2024
Decision Date	03/20/2025
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