FDA 510(k) Application Details - K241734

Device Classification Name	Catheter, Urethral   More FDA Info for this Device
510(K) Number	K241734
Device Name	Catheter, Urethral
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	GBM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/17/2024
Decision Date	03/05/2025
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