510(k) K231862 · PGW Ear, Nose, And Throat Stereotaxic Instrument
TruDi® Navigation System V3 (FG-2000-00)
| Applicant | Acclarent, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jul 21, 2023 |
| Received | Jun 23, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231862
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2025 | Integra LifeSciences Corp. (NeuroSciences) TruDi Navigation System - Multi Instrument Adapter; -
Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01; Open, Classified |
PGW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.