# K221123: WISE Cortical Strip (WCS)

- Pathway: 510(k) (Traditional)
- Applicant: Wise S.R.L.
- Decided: Nov 22, 2022 after 218 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.
- K053363: Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes, Intraoperative Subdural Electrodes, Ad-Tech Medical Instrument Corp (2006) Summary page 4.

## Indications for use
The WISE Cortical Strip is intended for intraoperative (≤ 24 hours) use with recording, monitoring and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain. The WCS is indicated as an aid to IntraOperative Neurophysiological Monitoring (IONM) during brain surgeries.

Source page: https://510kreport.com/device/K221123
Methodology: https://510kreport.com/methodology