Convatec Limited
Convatec Limited appears in FDA public data with 0 recalls, 10 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on April 1, 2026.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 10
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K252943 | GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women | April 1, 2026 |
| K250891 | Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2- | June 6, 2025 |
| K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter | June 22, 2022 |
| K190114 | Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) | April 30, 2019 |
| K180205 | AVELLE Negative Pressure Wound Therapy System | October 19, 2018 |
| K181206 | GentleCath Glide Intermittent Urinary Catheter | August 16, 2018 |
| K173675 | AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber | July 20, 2018 |
| K172924 | GentleCath Intermittent Urinary Catheter | November 21, 2017 |
| K161344 | GentleCath Glide Intermittent Catheter | September 20, 2016 |
| K152926 | AQUACEL Ag Surgical SP Dressing | January 21, 2016 |