# K222404: Evo® sEEG System

- Pathway: 510(k) (Traditional)
- Applicant: Neuroone Medical Technologies Corp.
- Decided: Oct 20, 2022 after 72 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: 8 generations back to K811452 (1981). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211367: Evo sEEG System, Neuroone Medical Technologies Corp. (2021) Summary page 5.

## Most influential descendants
- K250363: Depth Electrode (RSDE-08);  Depth Electrode (RSDE-10);  Depth Electrode (RSDE-12);  Depth Electrode (RSDE-14);  Depth Electrode (RSDE-16);  Depth Electrode (RSDE-16F);  Depth Electrode (RSDE-08S);  Depth Electrode (RSDE-10S);  Depth Electrode (RSDE-12S);  Depth Electrode (RSDE-14S);  Depth Electrode (RSDE-16S);  Depth Electrode (RSDE-16G);  Depth Electrode (RSDE-18);  Depth Electrode (RSDE-18F);  Depth Electrode (RSDE-18T);  Depth Electrode (RSDE-20);  Depth Electrode (RSDE-20F);  Dept (2025), 0 descendants of its own

## Indications for use
The Evo® sEEG System is intended for temporary (less than 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.

Source page: https://510kreport.com/device/K222404
Methodology: https://510kreport.com/methodology