Convatec
FDA 510(k) & PMA Approved Devices — 5 products
Total Devices5
Categories2
Latest FDA decision2026-08-05
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K260737 | Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18). | EZD | 2026-08-05 | View |
| 510(k) | K250699 | 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 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K) | EZD | 2025-07-01 | View |
| 510(k) | K243228 | Flexi-Seal AIR (with ENFit Connector) | KNT | 2025-03-28 | View |
| 510(k) | K232665 | GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) | EZD | 2024-01-25 | View |
| 510(k) | K162906 | Flexi-Seal PROTECT Fecal Management System | KNT | 2017-03-07 | View |
No matching devices.