# K190532: TruDi NAV Wire

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: May 3, 2019 after 60 days
- Product code: PGW (Ear, Nose, And Throat Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 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)
- K161697: Acclarent NavWire Sinus Navigation Guidewire, Acclarent, Inc. (2016) Summary page 4.

## Indications for use
TruDi™ NAV Wire is intended for use as an electromagnetically navigable guidewire to provide access and confirmation of placement in the patient anatomy. The device is intended for use during ENT procedures where reference to a rigid anatomical structure can be identified relative to a CT-based model of the anatomy.

Source page: https://510kreport.com/device/K190532
Methodology: https://510kreport.com/methodology