510(k) K261342 ยท QKA Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
Urocross Expander System (UES-2018-C1)
| Applicant | Prodeon Medical, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Jun 22, 2026 |
| Received | Apr 23, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261342
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.