# K021144: Subdural Strip Electrode

- Pathway: 510(k) (Abbreviated)
- Applicant: Nicolet Biomedical, Inc.
- Decided: Jun 24, 2002 after 76 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 K850342 (1985). 3 ancestors in all.
10 later devices descend from it; 1 cites it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970587: AD-Tech Subdural Electrode, Ad-Tech Medical Instrument Corp (1997) Summary page 1.
- K923803: AD-Tech Sub Dural Electrodeds, Ad-Tech Medical Instrument Corp (1992) Summary page 1.
- K850342: Wyler Subdural Strip Electrode, Ad-Tech Medical Instrument Corp (1985) Summary page 1.

## Most influential descendants
- K053363: Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes, Intraoperative Subdural Electrodes (2006), 9 descendants of its own
- 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 (2020), 4 descendants of its own
- K082474: PMT Subdural Cortical Electrodes (2009), 1 descendant of its own
- K242618: Layer 7-T (2025), 0 descendants of its own
- K221123: WISE Cortical Strip (WCS) (2022), 0 descendants of its own

## Indications for use
The Nicolet Subdural Strip Electrodes can be temporarily placed on the surface of the brain or subdural space in support of stimulating the brain or recording the brain's electrical activity.

Source page: https://510kreport.com/device/K021144
Methodology: https://510kreport.com/methodology