# K926424: Cortical Surf Epilepsy Elect Depth Elec Epilep Mon

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: Nov 19, 1993 after 331 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K961942: Epidural Peg Electrode (EP), Sphenoidal Electrode (Eds) and Foramen, Ovale Depth Electrode (ED-FO) for Epilepsy Monitori (1997), 2 descendants of its own
- K201678: iCE-SG Subcutaneous Electrode Arrays (2021), 1 descendant of its own
- K222706: iCE-SG2 Subcutaneous Electrode Kit (2022), 0 descendants of its own
- K082250: Auragen Cortical Surface Electrodes (2008), 0 descendants of its own

Source page: https://510kreport.com/device/K926424
Methodology: https://510kreport.com/methodology