FDA 510(k) Application Details - K221310

Device Classification Name	Endoscopic Irrigation/Suction System   More FDA Info for this Device
510(K) Number	K221310
Device Name	Endoscopic Irrigation/Suction System
Applicant	Changzhou Endoclean Medical Device Co., Ltd. West Side of 4th Floor, Building E2, No.9 Changyang Road Changzhou 213149 CN Other 510(k) Applications for this Company
Contact	Wang Qi 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	05/05/2022
Decision Date	10/07/2022
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