# K961942: Epidural Peg Electrode (EP), Sphenoidal Electrode (Eds) and Foramen, Ovale Depth Electrode (ED-FO) for Epilepsy Monitori

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: Aug 18, 1997 after 455 days
- Product code: GYC (Electrode, Cortical)
- Device class: 2
- Regulation: 21 CFR 882.1310
- 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 K926424 (1993). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926424: Cortical Surf Epilepsy Elect Depth Elec Epilep Mon, Radionics, Inc. (1993) Summary page 1.

## Most influential descendants
- K201678: iCE-SG Subcutaneous Electrode Arrays (2021), 1 descendant of its own
- K222706: iCE-SG2 Subcutaneous Electrode Kit (2022), 0 descendants of its own

## Indications for use
Radionics Epidural Peg, Sphenoidal and Foramen Ovale Depth Electrodes are indicated for intraoperative recording of electrical signals for epilepsy monitoring at the surface and subsurface levels of the brain.

Source page: https://510kreport.com/device/K961942
Methodology: https://510kreport.com/methodology