FDA 510(k) Application Details - K241956

Device Classification Name	Ureteroscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K241956
Device Name	Ureteroscope And Accessories, Flexible/Rigid
Applicant	Hunan Endoso Life Technology Co., Ltd. 4th floor, Building 10, Innovation and Entrepreneurship Center, 31 Dongfeng Road, Heping Street, Xiangtan Economic Xiangtan 411199 CN Other 510(k) Applications for this Company
Contact	Fu Wang 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	07/03/2024
Decision Date	01/22/2025
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