TruDi Navigation System
510(k) K192397
TruDi Navigation System is a medical device (FDA Class II; FDA product code PGW, Ear, Nose, And Throat Stereotaxic Instrument) made by Biosense Webster, cleared under FDA 510(k) K192397 on 30 Jan 2020, active as of 10 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK192397 | Date30 Jan 2020 | StatusActive |
Official records
- FDA 510(k) database K192397
Recalls
-
- Ongoing Z-0127-2024
When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical procedures of the Ear Nose and Throat (ENT) and ENT skull base surgery, which may cause delayed/prolonged surgery, cerebrospinal fluid leak, visual impairment, or skull base structural damage.
Timeline
- Cleared FDA 510(k) K192397
- Recall initiated FDA recalls Z-0127-2024
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PGW
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code PGW (Ear, Nose, And Throat Stereotaxic Instrument).
- Scopis Hybrid Navigation System EM by Scopis GmbH
- Acclarent ENT Navigation System by ACCLARENT, INC.
- Guidewire 0.6 Single Use by Fiagon GmbH
- Fusion Compact Navigation System by Medtronic Navigation Inc.
- FlexPointer 1.5 mm by Fiagon GmbH
- TruDi NAV Suction Instruments by ACCLARENT, INC.
- TGS Universal Headrest with Mounting Arm by Stryker Ent
- StealthStationTM S8 ENT Software by Medtronic Navigation Inc.
- Scopis Extended Instrument Set EM by Scopis GmbH
- ENT EM by Brainlab AG