# K231862: TruDi® Navigation System V3 (FG-2000-00)

- Pathway: 510(k) (Special)
- Applicant: Acclarent, Inc.
- Decided: Jul 21, 2023 after 28 days
- Product code: PGW (Ear, Nose, And Throat Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K911783 (1994). 17 ancestors in all.
No later device cites it as a predicate yet.
3 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192397: TruDi Navigation System, Biosense Webster (2020) Summary page 4.

## Recalls of this device
- Oct 3, 2025 · Class II · Z-0420-2026: It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specif

## Indications for use
The TruDi® Navigation system is intended for use during surgical procedures in ENT and ENT skull base surgery to support navigation of instruments to targeted anatomy, where reference to a rigid anatomical structure can be identified relative to a CT or MR based model.

Source page: https://510kreport.com/device/K231862
Methodology: https://510kreport.com/methodology