FDA 510(k) Application Details - K173758

Device Classification Name	Endoscopic Irrigation/Suction System   More FDA Info for this Device
510(K) Number	K173758
Device Name	Endoscopic Irrigation/Suction System
Applicant	Zhejiang Chuangxiang Medical Technology Co., LTD. 301B, No.22, XinYan Road Hanzhou 311100 CN Other 510(k) Applications for this Company
Contact	Lucius Long 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	12/11/2017
Decision Date	05/14/2018
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