# K202087: DIXI Medical Microdeep Micro-Macro Depth Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Dixi Medical
- Decided: Nov 18, 2021 after 478 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: 7 generations back to K811452 (1981). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163355: Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes, Ad-Tech Medical Instrument Corporation (2017) Summary page 4.

## Indications for use
The DIXI Medical Microdeep® Micro-Macro 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/K202087
Methodology: https://510kreport.com/methodology