510(k) K252943 ยท EZD Catheter, Straight
GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women
| Applicant | Convatec Limited, Deeside, Flintshire, GB |
| Decision | Substantially Equivalent, Apr 1, 2026 |
| Received | Sep 15, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252943
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.