FDA 510(k) Application Details - K250891

Device Classification Name	Tray, Catheterization, Sterile Urethral, With Or Without Catheter   More FDA Info for this Device
510(K) Number	K250891
Device Name	Tray, Catheterization, Sterile Urethral, With Or Without Catheter
Applicant	ConvaTec Limited First Avenue Deeside Industrial Park Deeside CH5 2NU GB Other 510(k) Applications for this Company
Contact	Alexandra Hyde Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	FCM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/25/2025
Decision Date	06/06/2025
Decision	SESK - SUBST EQUIV - KIT
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