FDA 510(k) Application Details - K243710

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K243710
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	Shenzhen Trious Medical Technology Co., Ltd Rm 102-2, Longtian Tongfuyu Ind Estate #11-3 & 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	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2024
Decision Date	04/11/2025
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