# 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

- Pathway: 510(k) (Traditional)
- Applicant: Ad-Tech Medical Instrument Corporation
- Decided: Jan 25, 2020 after 267 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.
4 later devices descend from it; 4 cite it directly.
1 of 10 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.

## Most influential descendants
- K242618: Layer 7-T (2025), 0 descendants of its own
- K221123: WISE Cortical Strip (WCS) (2022), 0 descendants of its own
- K211954: Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid (2022), 0 descendants of its own
- K201931: Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) (2021), 0 descendants of its own

## Indications for use
The Ad-Tech Subdural Electrodes (Strip/Intraoperative Strip, Grid/Intraoperative Grid, Dual-Sided Interhemispheric, Multi-Strip and Split Grid, Intraoperative Mapping Grid) 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/K191186
Methodology: https://510kreport.com/methodology