# K011992: FHC Microtargeting Drive System

- Pathway: 510(k) (Special)
- Applicant: FHC, Inc.
- Decided: Aug 14, 2001 after 49 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003776 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003776: Microtargeting Drive System, FHC, Inc. (2001) Summary page 2.

## Recalls of this device
- May 10, 2018 · Class II · Z-2353-2018: The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one 
- May 10, 2018 · Class II · Z-2359-2018: The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one 
- Oct 8, 2008 · Not classified · Z-0486-2009: Measuring fixture is incorrectly graduated.
- Oct 31, 2005 · Not classified · Z-0179-06: Power Assist microTargeting System may advance beyond intended target
- Oct 31, 2005 · Not classified · Z-0180-06: Power Assist microTargeting System may advance beyond intended target
- Mar 14, 2005 · Not classified · Z-0895-05: Potential for non-sterile pin to contaminate sterile field

## Indications for use
The FHC microTargeting® 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/K011992
Methodology: https://510kreport.com/methodology