# K053358: Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth Electrodes

- Pathway: 510(k) (Abbreviated)
- Applicant: Ad-Tech Medical Instrument Corp
- Decided: May 25, 2006 after 174 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: 5 generations back to K811452 (1981). 13 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 25 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.
- K964644: AD-Tech's Depth Electrode, Ad-Tech Medical Instrument Corp (1997) Summary page 1.
- K990788: AD-Tech's Foramen Ovale Electrode, Ad-Tech Medical Instrument Corp (1999) Summary page 1.
- K041604: Macro-Micro Depth Electrode, Ad-Tech Medical Instrument Corp (2004) Summary page 1.
- K861031: Wyler Sphenoidal Electrode, Ad-Tech Medical Instrument Corp (1986) Summary page 1.
- K042384: Neuroport Recording Microelectrode Array System, Cyberkinetics, Inc. (Cki) (2005) Summary page 1.

## Most influential descendants
- 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
- K222404: Evo® sEEG System (2022), 1 descendant of its own

## Indications for use
The AD-TECH Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.

Source page: https://510kreport.com/device/K053358
Methodology: https://510kreport.com/methodology