# K191739: Sterile LeadConfirm

- Pathway: 510(k) (Traditional)
- Applicant: Alpha Omega Engineering, Ltd.
- Decided: Jan 2, 2020 after 188 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: 1 generation back to K120098 (2012). 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)
- K120098: Sterile Disposables for Mer, Alpha Omega Engineering, Ltd. (2012) Summary page 4.

## Indications for use
The Alpha Omega Disposable Sterile LeadConfirm for MER is intended to be used in neurosurgery for connecting a compatible DBS Lead to a compatible recording and stimulation device. The Alpha Omega Disposable Sterile LeadConfirm for MER is indicated for assisting Neurosurgeons, in the operating room during functional neurosurgery, to aid in the placement of a compatible DBS Lead. The Alpha Omega Disposable Sterile LeadConfirm should only be used to connect a compatible DBS Lead to a compatible recording and stimulation device.

Source page: https://510kreport.com/device/K191739
Methodology: https://510kreport.com/methodology