FDA 510(k) Application Details - K243011

Device Classification Name	Catheter, Retention Type, Balloon   More FDA Info for this Device
510(K) Number	K243011
Device Name	Catheter, Retention Type, Balloon
Applicant	Guangdong Ecan Medical Co., Ltd. Building 1, No. 222, Xindu Road, Chengjiao Street, Conghua District Guangzhou 510920 CN Other 510(k) Applications for this Company
Contact	Liuyuan Han Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2024
Decision Date	06/16/2025
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