FDA 510(k) Application Details - K223097

Device Classification Name	Ureteroscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K223097
Device Name	Ureteroscope And Accessories, Flexible/Rigid
Applicant	CenterPoint Systems LLC 3338 Parkway Blvd West Valley City, UT 84119 US Other 510(k) Applications for this Company
Contact	Marybeth Gamber 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	09/30/2022
Decision Date	07/31/2023
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