510(k) K213283 ยท GBM Catheter, Urethral
GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
| Applicant | Convatec Limited, Deeside, GB |
| Decision | Substantially Equivalent, Jun 22, 2022 |
| Received | Oct 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213283
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.