# K140680: Leadpoint Focus Workststion, Leadpoint Focus Notebook System

- Pathway: 510(k) (Traditional)
- Applicant: Alpine Biomed Aps
- Decided: Dec 12, 2014 after 269 days
- Product code: GZL (Electrode, Depth)
- Device class: 2
- Regulation: 21 CFR 882.1330
- 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 K970943 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071364: Microtargeting Guideline 4000, FHC, Inc. (2007) Summary page 5.

## Indications for use
The Leadpoint microelectrode targeting system is intended to assist in neurosurgical procedures where recording of neuronal activity and stimulation of brain neurons will aid in the placement of depth electrodes. The Leadpoint microelectrode targeting system is intended to be used in the operating room by a neurosurgeon, neurologist, or clinical neurophysiologist.

Source page: https://510kreport.com/device/K140680
Methodology: https://510kreport.com/methodology