TruDi Navigation System
FDA 510(k) clearance K192397 · decided 2020-01-30
Clearance details
- K-number
- K192397
- Device name
- TruDi Navigation System
- Applicant
- Biosense Webster
- Decision
- Substantially Equivalent
- Date received
- 2019-09-03
- Decision date
- 2020-01-30
- Days to decision
- 149 days
- Clearance type
- Traditional
- Product code
- PGW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Irvin, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Cube 4D Navigation System, VirtuEye Pro (K261540) | Fiagon GmbH | 2026-06-02 |
| Stealth AXiS™ ENT clinical application (K253395) | Medtronic Navigation, Inc. | 2026-03-16 |
| Navient Image Guided Navigation System (ENT) (955-NC-NC) (K243053) | Claronav | 2025-06-20 |
| TruDi® Navigation System V3 (FG-2000-00) (K231862) | Acclarent, Inc. | 2023-07-21 |
| ENT EM (K223734) | Brainlab AG | 2023-04-27 |
| TruDi Shaver Blade (K221037) | Acclarent, Inc. | 2022-07-20 |
| Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit (K221098) | Stryker Corporation | 2022-07-12 |
| Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D (K211291) | Fiagon GmbH | 2021-07-19 |
| Instrument Clamps Electromagnetic (K202609) | Stryker Corporation | 2020-10-09 |
| TruDi Curette (K201174) | Acclarent, Inc. | 2020-08-12 |
| StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) (K200723) | Medtronic Navigation, Inc. | 2020-06-26 |
| TruDi Probe (K193453) | Acclarent, Inc. | 2020-03-23 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette recall (Z-0127-2024) | Acclarent, Inc. | 2023-10-20 |