FDA 510(k) Application Details - K182876

Device Classification Name	Cystoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K182876
Device Name	Cystoscope And Accessories, Flexible/Rigid
Applicant	UroViu Corporation 5337 - 14th Place SE Bellevue, WA 98006 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	10/12/2018
Decision Date	07/02/2019
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