# K082250: Auragen Cortical Surface Electrodes

- Pathway: 510(k) (Special)
- Applicant: Integra Neurosciences
- Decided: Oct 10, 2008 after 63 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.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The Auragen TM Cortical Surface Electrodes are intended for the intraoperative recording of EEG signals at the cortical surface of the brain.

Source page: https://510kreport.com/device/K082250
Methodology: https://510kreport.com/methodology