FDA 510(k) Application Details - K251599

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K251599
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	Hunan Vathin Medical Instrument Co., Ltd. 1/F, Building 12, Innovation Entrepreneurship Service Center No.9 Chuanqi West Road, Jiuhua Economic Development Zone Xiangtan 411100 CN Other 510(k) Applications for this Company
Contact	Ya Tang 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	05/27/2025
Decision Date	07/03/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review