FDA 510(k) Application Details - K231878

Device Classification Name	Ureteroscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K231878
Device Name	Ureteroscope And Accessories, Flexible/Rigid
Applicant	STERIS Corporation 5976 Heisley Rd Mentor, OH 44060 US Other 510(k) Applications for this Company
Contact	Carroll Martin 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	06/26/2023
Decision Date	07/25/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review