510(k) K191505 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Rezum System
| Applicant | Nxthera (A Boston Scientific Company), Marlboro MA, US |
| Decision | Substantially Equivalent, Aug 2, 2019 |
| Received | Jun 6, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191505
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.