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GYC — Electrode, Cortical Class II

FDA Device Classification

Classification Details

Product Code
GYC
Device Class
Class II
Regulation Number
882.1310
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250094neuralynxAtlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601April 14, 2025
K242618precision neuroscienceLayer 7-TMarch 30, 2025
K221123wiseWISE Cortical Strip (WCS)November 22, 2022
K211954spes medicaSubdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-November 10, 2022
K201931dixi medicalDixi Medical Intraoperative Subdural Electrodes (Strips and Grids)October 2, 2021
K191346blackrock microsystemsBlackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)February 14, 2020
K191186ad-tech medical instrument corporationSubdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative GridJanuary 25, 2020
K192764neurooneNeuroOne Cortical ElectrodeNovember 26, 2019
K183437cortecAirRay Subdural Cortical ElectrodesMarch 12, 2019
K180761micromedSD LTM STIM Cortical StimulatorJune 18, 2018
K173684g.tec medical engineeringg.Estim PROMay 4, 2018
K151354blackrock neuromedCervello STIMJanuary 27, 2016
K110410nihon kohdenMS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)August 4, 2011
K102802integra lifesciences corporationINTEGRA ELECTRODE TUNNELING NEEDLENovember 23, 2010
K082629chatten associatesS12X WITH ESAX OPTIONJuly 1, 2009
K082474pmtPMT SUBDURAL CORTICAL ELECTRODESMay 8, 2009
K072964cardinal healthNICOLET CORTICAL STIMULATORDecember 30, 2008
K082250integra neurosciencesAURAGEN CORTICAL SURFACE ELECTRODESOctober 10, 2008
K053363ad-tech medical instrumentDUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAMay 30, 2006
K021144nicolet biomedicalSUBDURAL STRIP ELECTRODEJune 24, 2002