510(k) K163416 · PGW Ear, Nose, And Throat Stereotaxic Instrument
Fiagon Navigation PointerTube Straight and PointerTube Keat
| Applicant | Fiagon GmbH, Hennigsdorf, DE |
| Decision | Substantially Equivalent, Feb 16, 2017 |
| Received | Dec 5, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163416
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.