FDA 510(k) Application Details - K221158

Device Classification Name	Ureteroscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K221158
Device Name	Ureteroscope And Accessories, Flexible/Rigid
Applicant	Guangzhou Red Pine Medical Instrument Co., Ltd. Room 303, 308, No. 12, Luoxuan 3 Road, Guangzhou International Bioisland Guangzhou 510200 CN Other 510(k) Applications for this Company
Contact	Lifang Zhang 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	04/21/2022
Decision Date	03/06/2023
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