510(k) K161344 ยท KOD Catheter, Urological
GentleCath Glide Intermittent Catheter
| Applicant | Convatec Limited, Deeside, GB |
| Decision | Substantially Equivalent, Sep 20, 2016 |
| Received | May 13, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161344
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.