# K012850: Recording and Stimulating Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, A Division of Tyco Healthcare Group LP
- Decided: Nov 19, 2001 after 87 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 K991077 (1999). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991399: Radionics Microelectrode Kit, Radionics, Inc. (1999) Summary page 1.
- K991077: Microelectroencephalography Professional System 5000 (Eeg Pro System 5000), Microrecording Systems Consultants, LLC (1999) Summary page 1.

## Most influential descendants
- K170959: DIXI Medical Microdeep Depth Electrode (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
- K253970: Wovyn Depth Electrode (2026), 0 descendants of its own

## Indications for use
T'o record cleetrical activity or evoke a responsc through stimulation for the purposc of brain wmapping during (unctional neurosurgical procedures.

Source page: https://510kreport.com/device/K012850
Methodology: https://510kreport.com/methodology