GYC · Class II · 21 CFR 882.1310

FDA Product Code GYC: Electrode, Cortical

Leading manufacturers include Radionics, Inc., Integra LifeSciences Corporation and G.Tec Medical Engineering GmbH.

32
Total
32
Cleared
214d
Avg days
1985
Since
Stable submission activity - 2 submissions in the last 2 years
Review times improving: avg 149d recently vs 218d historically

FDA 510(k) Cleared Electrode, Cortical Devices (Product Code GYC)

32 devices
1–24 of 32
Cleared Apr 14, 2025
Atlas Stim Headbox (NK) (31-0601-0077)
K250094
Neuralynx, Inc.
Neurology · 90d
Cleared Mar 30, 2025
Layer 7-T
K242618
Precision Neuroscience, Corp.
Neurology · 208d
Cleared Nov 22, 2022
WISE Cortical Strip (WCS)
K221123
Wise S.R.L.
Neurology · 218d
Cleared Nov 10, 2022
Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid
K211954
Spes Medica Srl
Neurology · 505d
Cleared Oct 02, 2021
Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
K201931
Dixi Medical
Neurology · 446d
Cleared Feb 14, 2020
Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)
K191346
Blackrock Microsystems
Neurology · 270d
Cleared Jan 25, 2020
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
K191186
Ad-Tech Medical Instrument Corporation
Neurology · 267d
Cleared Nov 26, 2019
NeuroOne Cortical Electrode
K192764
Neuroone, Inc.
Neurology · 57d
Cleared Mar 12, 2019
AirRay Subdural Cortical Electrodes
K183437
Cortec GmbH
Neurology · 90d
Cleared Jun 18, 2018
SD LTM STIM Cortical Stimulator
K180761
Micromed S.P.A.
Neurology · 87d
Cleared May 04, 2018
g.Estim PRO
K173684
G.Tec Medical Engineering GmbH
Neurology · 154d
Cleared Nov 23, 2010
INTEGRA ELECTRODE TUNNELING NEEDLE
K102802
Integra LifeSciences Corporation
Neurology · 57d
Cleared Aug 18, 1997
EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI
K961942
Radionics, Inc.
Neurology · 455d
Cleared Nov 19, 1993
CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON
K926424
Radionics, Inc.
Neurology · 331d
Cleared Apr 21, 1993
OJEMANN CORTICAL STIMULATOR
K924226
Radionics, Inc.
Neurology · 243d

About Product Code GYC - Regulatory Context

510(k) Submission Activity

32 total 510(k) submissions under product code GYC since 1985, with 32 receiving FDA clearance (average review time: 214 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - GYC Product Code

Recent submissions under GYC have taken an average of 149 days to reach a decision - down from 218 days historically, suggesting improved FDA processing for this classification.

GYC devices are reviewed by the Neurology panel. Browse all Neurology devices →