FDA 510(k) Application Details - K243830

Device Classification Name	Stent, Ureteral   More FDA Info for this Device
510(K) Number	K243830
Device Name	Stent, Ureteral
Applicant	Shenzhen Trious Medical Technology Co., Ltd Rm 102-2, Longtian Tongfuyu Ind Estate #11-3, and Rm 401 & 402, Bldg D3, YingZhan S&T Estate, Longtian Tongfuyu Rd #8; Shenzhen CN Other 510(k) Applications for this Company
Contact	Yingfang Yi Other 510(k) Applications for this Contact
Regulation Number	876.4620   More FDA Info for this Regulation Number
Classification Product Code	FAD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/13/2024
Decision Date	05/14/2025
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