510(k) K193453 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument
TruDi Probe
| Applicant | Acclarent, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Mar 23, 2020 |
| Received | Dec 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193453
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.