Convatec, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Cure Catheter Closed System, Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus, AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE
7
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Convatec, Inc. Gastroenterology & Urology ✕
5 devices
Cleared
Nov 08, 2023
Cure Catheter Closed System
Gastroenterology & Urology
266d
Cleared
Nov 17, 2022
Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus
Gastroenterology & Urology
168d
Cleared
Apr 26, 2012
FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM
Gastroenterology & Urology
255d
Cleared
CT
Aug 19, 2011
VITALA CONTINENCE CONTROL DEVICE
Gastroenterology & Urology
95d
Cleared
CT
Dec 01, 2010
VITALA CONTINENCE CONTROL DEVICE
Gastroenterology & Urology
89d