Irvine, CA, US · 7 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| PGW | — | — | — | 4 | 2023-07-21 |
| PNZ | Eustachian Tube Balloon Dilation Device | Class II | Ear, Nose, Throat | 2 | 2026-02-19 |
| LRC | Instrument, Ent Manual Surgical | Class I | Ear, Nose, Throat | 1 | 2020-08-27 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-09-21 | Class II | Ongoing | Z-0127-2024 | TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005 | — | When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intend… |
| 2021-11-12 | Class II | Ongoing | Z-0415-2022 | TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z | — | Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-02-19 | K253612 | Acclarent AERA Eustachian Tube Balloon Dilation System | PNZ | Class II | Ear, Nose, Throat |
| 2023-12-13 | K230742 | ACCLARENT AERA Eustachian Tube Dilation System | PNZ | Class II | Ear, Nose, Throat |
| 2023-07-21 | K231862 | TruDi® Navigation System V3 (FG-2000-00) | PGW | — | — |
| 2022-07-20 | K221037 | TruDi Shaver Blade | PGW | — | — |
| 2020-08-27 | K201115 | Next Generation Balloon Dilation System | LRC | Class I | Ear, Nose, Throat |
| 2020-08-12 | K201174 | TruDi Curette | PGW | — | — |
| 2020-03-23 | K193453 | TruDi Probe | PGW | — | — |