# K121950: Microtargeting XL Star Drive System

- Pathway: 510(k) (Special)
- Applicant: FHC, Inc.
- Decided: Jul 26, 2012 after 23 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: 2 generations back to K003776 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092562: Microtargeting Star Drive System, Components, FHC, Inc. (2009) Summary page 1.

## Indications for use
The FHC microTargeting TM XL STar TM Drive System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.

Source page: https://510kreport.com/device/K121950
Methodology: https://510kreport.com/methodology