# K043091: Navigus Nexdrive, Model MI-3000

- Pathway: 510(k) (Traditional)
- Applicant: Image-Guided Neurologics, Inc.
- Decided: Feb 7, 2005 after 90 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.
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.

## 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
The NeXdrive Disposable Micro-drive for use the with FHC microTargeting® Drive System Display and Power Assist Accessories is intended to be used in conjunction with the NavigusTM family of Trajectory Guides for the precise positioning of microelectrodes, stimulating electrodes, implantable electrodes, or other instruments in the brain or nervous system.

Source page: https://510kreport.com/device/K043091
Methodology: https://510kreport.com/methodology