FDA 510(k) Application Details - K243196

Device Classification Name	Cystoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K243196
Device Name	Cystoscope And Accessories, Flexible/Rigid
Applicant	UroViu Corporation 4546 El Camino Real Suite 214 Los Altos, CA 94022 US Other 510(k) Applications for this Company
Contact	Thomas Lawson 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	10/01/2024
Decision Date	12/13/2024
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