# GYC: Electrode, Cortical

- Device class: 2; regulation: 21 CFR 882.1310; FDA's rule: 510(k) required
- FDA decisions: 32
- 510(k) review time 2021–2025: median 218 days (middle half 208–446)
- Recalls: 5 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2009: 2
- 2010: 1
- 2011: 1
- 2016: 1
- 2018: 2
- 2019: 2
- 2020: 2
- 2021: 1
- 2022: 2
- 2025: 2

## Most-cited predicates
- K924226: Ojemann Cortical Stimulator (1993), cited by 5
- K053363: Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes, Intraoperative Subdural Electrodes (2006), cited by 5
- K072964: Nicolet Cortical Stimulator (2008), cited by 4
- 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), cited by 4
- K082629: S12X with Esax Option (2009), cited by 2
- K923803: AD-Tech Sub Dural Electrodeds (1992), cited by 2
- K970587: AD-Tech Subdural Electrode (1997), cited by 2
- K926424: Cortical Surf Epilepsy Elect Depth Elec Epilep Mon (1993), cited by 2
- K110410: MS-120BK Electric Stimulator (Extension Unit) (2011), cited by 2
- K082474: PMT Subdural Cortical Electrodes (2009), cited by 1

Source page: https://510kreport.com/product-code/GYC
Data by year (CSV): https://510kreport.com/product-code/GYC.csv