FDA 510(k) Application Details - K243228

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K243228
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	Convatec First Avenue, Deeside Industrial Estate Deeside Flintshire CH5 2NU GB Other 510(k) Applications for this Company
Contact	Michael Chitiyo Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	KNT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/08/2024
Decision Date	03/28/2025
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