Convatec - FDA 510(k) Cleared Devices
Recent clearances: Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16), Cure Twist Female 8 Catheter (T8), Flexi-Seal AIR (with ENFit Connector)
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Convatec Gastroenterology & Urology ✕
6 devices
Cleared
Aug 05, 2026
Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16)
Gastroenterology & Urology
152d
Cleared
Jul 01, 2025
Cure Twist Female 8 Catheter (T8)
Gastroenterology & Urology
116d
Cleared
Mar 28, 2025
Flexi-Seal AIR (with ENFit Connector)
Gastroenterology & Urology
171d
Cleared
Jan 25, 2024
GentleCath Air for Women (CH10)
Gastroenterology & Urology
147d
Cleared
Mar 07, 2017
Flexi-Seal PROTECT Fecal Management System
Gastroenterology & Urology
141d
Cleared
CT
Apr 02, 2010
VITALA CONTINENCE CONTROL DEVICE
Gastroenterology & Urology
469d