FDA 510(k) Application Details - K211032

Device Classification Name	Catheter, Urological   More FDA Info for this Device
510(K) Number	K211032
Device Name	Catheter, Urological
Applicant	UroGen Pharma Ltd 9 Ha'Ta'asiya Street Ra'anana 4365405 IL Other 510(k) Applications for this Company
Contact	James G. Otinger Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	KOD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/2021
Decision Date	11/19/2021
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