510(k) K261540 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument
Cube 4D Navigation System, VirtuEye Pro
| Applicant | Fiagon GmbH, Hennigsdorf, DE |
| Decision | Substantially Equivalent, Jun 2, 2026 |
| Received | May 8, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K261540
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.