510(k) K211032 ยท KOD Catheter, Urological
Urinary Catheter 12 Fr, Urinary Catheter 16 Fr
| Applicant | Urogen Pharma, Ltd., Ra'Anana, IL |
| Decision | Substantially Equivalent, Nov 19, 2021 |
| Received | Apr 7, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211032
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.