510(k) K180948 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument
TruDi NAV Suction Instruments
| Applicant | Acclarent, Inc., Irvin CA, US |
| Decision | Substantially Equivalent, Jul 20, 2018 |
| Received | Apr 11, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180948
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2024 | Integra LifeSciences Corp. TruDi NAV Suction, 0 Degrees;
Model/Catalog Number: TDNS000Z.
TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in ENT medicine and skul Open, Classified |
PGW | None listed |
| Nov 12, 2021 | Acclarent, Inc. TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z Open, Classified |
PGW | None listed |
| Mar 6, 2019 | Acclarent, Inc. TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877 Terminated |
PGW | None listed |
| Mar 6, 2019 | Acclarent, Inc. TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884 Terminated |
PGW | None listed |
| Mar 6, 2019 | Acclarent, Inc. TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891 Terminated |
PGW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.