510(k) K192397 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument
TruDi Navigation System
| Applicant | Biosense Webster, Irvin CA, US |
| Decision | Substantially Equivalent, Jan 30, 2020 |
| Received | Sep 3, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192397
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 20, 2023 | Acclarent, Inc. TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005 Open, Classified |
PGW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.