# K024201: Navigus Fiducial Marker System, Models FM-1000, FM-2000

- Pathway: 510(k) (Traditional)
- Applicant: Image-Guided Neurologics, Inc.
- Decided: Mar 12, 2003 after 82 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 Fiducial Marker System is intended to provide fixed reference point(s) in patients requiring stereotactic surgery. The device is provided sterile and is for one time use only.

Source page: https://510kreport.com/device/K024201
Methodology: https://510kreport.com/methodology