FDA 510(k) Application Details - K233275

Device Classification Name	Ureteroscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K233275
Device Name	Ureteroscope And Accessories, Flexible/Rigid
Applicant	Gyrus ACMI, Inc 9600 Louisiana Avenue North Brooklyn Park, MN 55445 US Other 510(k) Applications for this Company
Contact	Andrea Curria 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	09/29/2023
Decision Date	03/25/2024
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