# K050772: Navigus Reusable Passive Probe, Model SP-2000

- Pathway: 510(k) (Traditional)
- Applicant: Image-Guided Neurologics, Inc.
- Decided: Apr 21, 2005 after 27 days
- Product code: HAW (Neurological 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Navigus Reusable Passive Probe is intended to be used in conjunction with the Navigus family of trajectory guides and the Medtronic StealthStation® Treatment Guidance System for patient registration and navigation.

Source page: https://510kreport.com/device/K050772
Methodology: https://510kreport.com/methodology