510(k) K250584 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Rezum System
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Jun 11, 2025 |
| Received | Feb 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250584
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.