# K192397: TruDi Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster
- Decided: Jan 30, 2020 after 149 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: 6 generations back to K911783 (1994). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173628: Acclarent ENT Navigation System, Acclarent, Inc. (2018) Summary page 4.
- K162176: Fiagon Navigation System, Fiagon GmbH (2016) Summary page 4.

## Most influential descendants
- K231862: TruDi® Navigation System V3 (FG-2000-00) (2023), 0 descendants of its own

## Recalls of this device
- Sep 21, 2023 · Class II · 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

## 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 rigid anatomic structure can be identified relative to a CT or MR based model.

Source page: https://510kreport.com/device/K192397
Methodology: https://510kreport.com/methodology