FDA 510(k) Application Details - K243117

Device Classification Name	Ureteroscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K243117
Device Name	Ureteroscope And Accessories, Flexible/Rigid
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	Jing Du Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FGB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2024
Decision Date	01/29/2025
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