# K040334: Navigus Passive Probe, Model NP-1000

- Pathway: 510(k) (Traditional)
- Applicant: Image-Guided Neurologics, Inc.
- Decided: Oct 4, 2004 after 236 days
- Product code: HAW (Neurological 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K233155: ClearPointer Optical Navigation Wand (2024), 0 descendants of its own

## Recalls of this device
- Oct 4, 2007 · Not classified · Z-0849-2008: Sterilty (package integrity) Compromised: Some failures were for damage to the outer pouch, while another set of failures were for the seals on this pouch. The seal between the inner tray and lid has 

## Indications for use
Intended Use: The Navigus 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. The device is provided sterile and for single use.

Source page: https://510kreport.com/device/K040334
Methodology: https://510kreport.com/methodology