# K120098: Sterile Disposables for Mer

- Pathway: 510(k) (Traditional)
- Applicant: Alpha Omega Engineering, Ltd.
- Decided: Jun 12, 2012 after 152 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K191739: Sterile LeadConfirm (2020), 0 descendants of its own

## Indications for use
Alpha Omega's Sterile Disposable NeuroProbes for MER devices are intended to be used in neurosurgery for temporary stimulation of, or recording electrical signals of a small area in the brain. Alpha Omega's sterile Disposable Cannulas for MER are intended for guiding the Neurorobes in Neurosurgery for temporary stimulation of, or recording electrical signals of a smallI area in the brain. Alpha Omega's Sterile Disposable Recording Cables for MER are intended to be used in neurosurgery for connecting Neurorobes to recording and stimulation device. Alpha Omega's Sterile Disposable Neurorobes, Cannulas and Recording Cables for MER are indicated for assisting Neurosurgeons, in the operation room during functional neurosurgery, to aid in placement of depth electrodes.

Source page: https://510kreport.com/device/K120098
Methodology: https://510kreport.com/methodology