510(k) K180237 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Rezum System
| Applicant | Nxthera, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Feb 27, 2018 |
| Received | Jan 29, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180237
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.