FDA 510(k) Application Details - K220036

Device Classification Name	Catheter, Urological   More FDA Info for this Device
510(K) Number	K220036
Device Name	Catheter, Urological
Applicant	Well Lead Medical Co., Ltd. No.47, Guomao Avenue South, Hualong, Panyu Guangzhou 511434 CN Other 510(k) Applications for this Company
Contact	Jenny Zhu Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	KOD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/05/2022
Decision Date	12/16/2022
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