# K011971: Navigus Trajectory Guide Biopsy Kit, Models BK-7000 and 8000

- Pathway: 510(k) (Traditional)
- Applicant: Image-Guided Neurologics, Inc.
- Decided: Aug 3, 2001 after 39 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
Intended Use: The Navigus Trajectory Guide Biopsy Kit is intended to provide stereotactic guidance for the placement of a brain biopsy needle in conjunction with the use of a Frameless Image-Guided Workstation System using preoperative MR and/or CT imaging. The kit is ETO sterilized and for one time use.

Source page: https://510kreport.com/device/K011971
Methodology: https://510kreport.com/methodology