FDA 510(k) Application Details - K250448

Device Classification Name	Catheter, Nephrostomy   More FDA Info for this Device
510(K) Number	K250448
Device Name	Catheter, Nephrostomy
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	Yi Yingfang Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LJE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/18/2025
Decision Date	07/03/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review