# K040979: Elekta Microdrive, Model 916716

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Instrument AB
- Decided: Jul 23, 2004 after 99 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
Longest line of descent: 3 generations back to K811452 (1981). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011775: Micro Targeting Drive System, FHC, Inc. (2001) Summary page 2.

## Indications for use
The ELEKTA Microdrive is intended to be used for accurate positioning of electrodes or other devices during stereotactic neurosurgery.

Source page: https://510kreport.com/device/K040979
Methodology: https://510kreport.com/methodology