FDA 510(k) Application Details - K211686

Device Classification Name	Ureteroscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K211686
Device Name	Ureteroscope And Accessories, Flexible/Rigid
Applicant	Shanghai SeeGen Photoelectric Technology Co., Ltd 3 Floor, Building No.1, 4299 JinDu Road, Minhang District Shanghai 201108 CN Other 510(k) Applications for this Company
Contact	Yvonne Fei 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	06/02/2021
Decision Date	02/22/2022
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