510(k) K253395 · PGW Ear, Nose, And Throat Stereotaxic Instrument
Stealth AXiS ENT clinical application
| Applicant | Medtronic Navigation, Inc., Lafayette CO, US |
| Decision | Substantially Equivalent, Mar 16, 2026 |
| Received | Sep 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253395
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.