# 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

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Sinovation Medical Technology Co., Ltd.
- Decided: Nov 5, 2025 after 268 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: 9 generations back to K811452 (1981). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222404: Evo® sEEG System, Neuroone Medical Technologies Corp. (2022) Summary page 5.
- K170959: DIXI Medical Microdeep Depth Electrode, Dixi Medical (2017) Summary page 5.
- K163355: Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes, Ad-Tech Medical Instrument Corporation (2017) Summary page 5.

## Indications for use
The Depth Electrode 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/K250363
Methodology: https://510kreport.com/methodology