FDA 510(k) Application Details - K250695

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K250695
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	Shenzhen HugeMed Medical Technical Development Co., Ltd. 401, 501, Building 4, Haizhi Technology Park, Fortis No. 17 Bulan Road,Xialilang Community, Nanwan Street Shenzhen 518112 CN Other 510(k) Applications for this Company
Contact	Cathy Shi 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	03/07/2025
Decision Date	07/08/2025
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