# K022100: Navigus Manual Disposable Microdrive with Digital Display, Models MI-1000 & MI-1010

- Pathway: 510(k) (Traditional)
- Applicant: Image-Guided Neurologics, Inc.
- Decided: Sep 25, 2002 after 89 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 2 (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
- Jun 11, 2014 · Class II · Z-2118-2014: Potential for misalignment of the Z-stage scale. Using one of these devices for a procedure could result in the microelectrode being inserted to an incorrect target depth.
- 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 Manual Disposable Micro-drive with Digital Display 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/K022100
Methodology: https://510kreport.com/methodology