FDA 510(k) Applications Submitted by Convatec

FDA 510(k) Number	Submission Date	Device Name	Applicant
K250699	03/07/2025	Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female	Convatec
K162906	10/17/2016	Flexi-Seal PROTECT Fecal Management System	ConvaTec
K232665	08/31/2023	GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)	ConvaTec
K071763	06/29/2007	AMADEUS ADAPTIVE COMPRESSION THERAPY	CONVATEC
K083785	12/19/2008	VITALA CONTINENCE CONTROL DEVICE	CONVATEC
K243228	10/08/2024	Flexi-Seal AIR (with ENFit Connector)	Convatec
K091034	04/10/2009	AQUACEL AG SURGICAL	CONVATEC