Convatec Limited
FDA 510(k) & PMA Approved Devices — 10 products
Total Devices10
Categories7
Latest FDA decision2026-04-01
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K252943 | GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women | EZD | 2026-04-01 | View |
| 510(k) | K250891 | Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C | FCM | 2025-06-06 | View |
| 510(k) | K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter | GBM | 2022-06-22 | View |
| 510(k) | K190114 | Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) | KNT | 2019-04-30 | View |
| 510(k) | K180205 | AVELLE Negative Pressure Wound Therapy System | OMP | 2018-10-19 | View |
| 510(k) | K181206 | GentleCath Glide Intermittent Urinary Catheter | GBM | 2018-08-16 | View |
| 510(k) | K173675 | AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber | FRO | 2018-07-20 | View |
| 510(k) | K172924 | GentleCath Intermittent Urinary Catheter | KOD | 2017-11-21 | View |
| 510(k) | K161344 | GentleCath Glide Intermittent Catheter | KOD | 2016-09-20 | View |
| 510(k) | K152926 | AQUACEL Ag Surgical SP Dressing | FRO | 2016-01-21 | View |
No matching devices.