510(k) K261141 ยท EZL Catheter, Retention Type, Balloon
OpenFlo Urinary Catheter
| Applicant | Urolution Medical, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Oct 6, 2026 |
| Received | Apr 7, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261141
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.