FDA 510(k) Application Details - K213283

Device Classification Name	Catheter, Urethral   More FDA Info for this Device
510(K) Number	K213283
Device Name	Catheter, Urethral
Applicant	ConvaTec Limited GDC, First Avenue, Deeside industrial Park Deeside CH5 2NU GB Other 510(k) Applications for this Company
Contact	Louise Hollywood Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	GBM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/01/2021
Decision Date	06/22/2022
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