# K193453: TruDi Probe

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: Mar 23, 2020 after 101 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: 5 generations back to K911783 (1994). 14 ancestors in all.
No later device cites it as a predicate yet.
3 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150473: FlexPointer 1.5 mm, Fiagon GmbH (2015) Summary page 4.

## Indications for use
The TruDi™ Probe is intended for use with the TruDi™ Navigation System to locate anatomical structures during surgical procedures in ENT and ENT skull base surgery.

Source page: https://510kreport.com/device/K193453
Methodology: https://510kreport.com/methodology