# K191346: Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)

- Pathway: 510(k) (Traditional)
- Applicant: Blackrock Microsystems
- Decided: Feb 14, 2020 after 270 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: 3 generations back to K850342 (1985). 5 ancestors in all.
No later device cites it as a predicate yet.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053363: Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes, Intraoperative Subdural Electrodes, Ad-Tech Medical Instrument Corp (2006) Summary page 4.

## Indications for use
Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) are intended for temporary (<30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.

Source page: https://510kreport.com/device/K191346
Methodology: https://510kreport.com/methodology