FDA 510(k) Application Details - K223040

Device Classification Name	Cystoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K223040
Device Name	Cystoscope And Accessories, Flexible/Rigid
Applicant	Medivators Inc 14605 28th Ave North Minneapolis, MN 55447 US Other 510(k) Applications for this Company
Contact	Disha Kabrawala Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FAJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2022
Decision Date	03/01/2023
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