510(k) K160417 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Rezum System
| Applicant | Nxthera, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Mar 17, 2016 |
| Received | Feb 16, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160417
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2017 | NXTHERA Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138 Maple Grove, MN 55369 USA.
Intended to relieve symptoms, obstructions, and reduce prostate t Terminated |
KNS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.