# K990788: AD-Tech's Foramen Ovale Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Ad-Tech Medical Instrument Corp
- Decided: Nov 2, 1999 after 237 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 K891920 (1989). 1 ancestor in all.
12 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891920: AD-Tech's Depth Electrode, Ad-Tech Medical Instrument Corp (1989) Summary page 1.

## Most influential descendants
- K053358: Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth Electrodes (2006), 11 descendants of its own
- K170959: DIXI Medical Microdeep Depth Electrode (2017), 5 descendants of its own
- K163355: Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes (2017), 5 descendants of its own
- K211367: Evo sEEG System (2021), 2 descendants of its own
- K213170: SENSOSEEG Depth Electrodes (2023), 1 descendant of its own

## Indications for use
The foramen ovale electrode is designed for monitoring brain electrical activity (eeg) or defining the location of epileptogenic foci in patients with intractable epilepsy. The foramen ovale electrode is intended for “Surgical Use Only” and “Not Intended for Implantation” This product should only be used by a physician/surgeon trained in the use of foramen ovate electrodes.

Source page: https://510kreport.com/device/K990788
Methodology: https://510kreport.com/methodology