510(k) K252572 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
Prodeon Urethral Sheath System
| Applicant | Prodeon Medical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Oct 7, 2025 |
| Received | Aug 14, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252572
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.