# K253970: Wovyn Depth Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Sensomedical Labs, Ltd.
- Decided: Apr 17, 2026 after 127 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). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213170: SENSOSEEG Depth Electrodes, Sensomedical Labs, Ltd. (2023) Summary page 5.
- K151790: PMT Platinum Depthalon Depth Electrode, Pmt Corporation (2016) Summary page 5.

## Indications for use
Sensomedical Wovyn 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.

Source page: https://510kreport.com/device/K253970
Methodology: https://510kreport.com/methodology