FDA 510(k) Application Details - K230475

Device Classification Name	Ureteroscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K230475
Device Name	Ureteroscope And Accessories, Flexible/Rigid
Applicant	HUGER Medical Instrument Co., Ltd. Building 26A, No. 3825, Xinzhuan Highway, Dongjing Town, Songjiang District Shanghai 201619 CN Other 510(k) Applications for this Company
Contact	Lei Lu 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	02/22/2023
Decision Date	11/03/2023
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