510(k) K253525 ยท QKA Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
Urocross Expander System (Model Numbers ES2018 and ES3025)
| Applicant | Prodeon Medical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Mar 12, 2026 |
| Received | Nov 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253525
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.