510(k) K221037 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument
TruDi Shaver Blade
| Applicant | Acclarent, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jul 20, 2022 |
| Received | Apr 7, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221037
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.