# K013396: Alpha Drive System

- Pathway: 510(k) (Special)
- Applicant: Alpha Omega, Ltd.
- Decided: Aug 7, 2002 after 296 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
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.

## Indications for use
Alpha Omega Alpha Drive system is intended to be used to assist neurosurgeons in the operating room during functional neurosurgery and to aid in the placement of depth electrode.

Source page: https://510kreport.com/device/K013396
Methodology: https://510kreport.com/methodology