# K211954: Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid

- Pathway: 510(k) (Traditional)
- Applicant: Spes Medica Srl
- Decided: Nov 10, 2022 after 505 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: 4 generations back to K850342 (1985). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191186: Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode, Ad-Tech Medical Instrument Corporation (2020) Summary page 4.

## Indications for use
The Recording and stimulating for Central Nervous System electrodes (Strip/lntraoperative Strip, Grid/lntraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid) are intended for limited ( 24 hours) use with recording, monitoring, and stimulation equipment for electrical stimulation, monitoring and recording of the signals on the surface of the brain for intraoperative monitoring, brain mapping and location of epileptogenic foci.

Source page: https://510kreport.com/device/K211954
Methodology: https://510kreport.com/methodology