FDA 510(k) Application Details - K213334

Device Classification Name	Ureteroscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K213334
Device Name	Ureteroscope And Accessories, Flexible/Rigid
Applicant	Auris Health Inc 150 Shoreline Drive Redwood City, CA 94065 US Other 510(k) Applications for this Company
Contact	Angela Wong 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	10/06/2021
Decision Date	04/29/2022
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