Product Code: GYC FDA class 2 21 CFR 882.1310

Electrode, Cortical

Neurology

The Cortical Electrode is a recording electrode placed directly on the surface of the cerebral cortex, used during intraoperative neurophysiological monitoring or electrocorticography to map brain function and identify epileptic foci. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is GYC under regulation 21 CFR 882.1310 in the Neurology specialty. It is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: GYC
Device Class: FDA class 2
Regulation Number: 882.1310
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 32 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250094	Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014)	Apr 14, 2025	Substantially Equivalent	Neuralynx, Inc.
K242618	Layer 7-T	Mar 30, 2025	Substantially Equivalent	Precision Neuroscience, Corp.
K221123	WISE Cortical Strip (WCS)	Nov 22, 2022	Substantially Equivalent	Wise S.R.L.
K211954	Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid	Nov 10, 2022	Substantially Equivalent	Spes Medica Srl
K201931	Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)	Oct 02, 2021	Substantially Equivalent	Dixi Medical
K191346	Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)	Feb 14, 2020	Substantially Equivalent	Blackrock Microsystems
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	Jan 25, 2020	Substantially Equivalent	Ad-Tech Medical Instrument Corporation
K192764	NeuroOne Cortical Electrode	Nov 26, 2019	Substantially Equivalent	Neuroone, Inc.
K183437	AirRay Subdural Cortical Electrodes	Mar 12, 2019	Substantially Equivalent	Cortec GmbH
K180761	SD LTM STIM Cortical Stimulator	Jun 18, 2018	Substantially Equivalent	Micromed S.P.A.
K173684	g.Estim PRO	May 04, 2018	Substantially Equivalent	G.Tec Medical Engineering GmbH
K151354	Cervello STIM	Jan 27, 2016	Substantially Equivalent	Blackrock Neuromed
K110410	MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)	Aug 04, 2011	Substantially Equivalent	Nihon Kohden Corp.
K102802	INTEGRA ELECTRODE TUNNELING NEEDLE	Nov 23, 2010	Substantially Equivalent	Integra LifeSciences Corporation
K082629	S12X WITH ESAX OPTION	Jul 01, 2009	Substantially Equivalent	Chatten Associates, Inc.
K082474	PMT SUBDURAL CORTICAL ELECTRODES	May 08, 2009	Substantially Equivalent	Pmt Corp.
K072964	NICOLET CORTICAL STIMULATOR	Dec 30, 2008	Substantially Equivalent	Cardinal Health, Inc.
K082250	AURAGEN CORTICAL SURFACE ELECTRODES	Oct 10, 2008	Substantially Equivalent	Integra Neurosciences
K053363	DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES	May 30, 2006	Substantially Equivalent	Ad-Tech Medical Instrument Corp
K021144	SUBDURAL STRIP ELECTRODE	Jun 24, 2002	Substantially Equivalent	Nicolet Biomedical, Inc.
K992194	CORTICAL MAPPING UNIT, MODEL CMU	Sep 13, 1999	Substantially Equivalent	Ad-Tech Medical Instrument Corp
K961942	EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI	Aug 18, 1997	Substantially Equivalent	Radionics, Inc.
K970587	AD-TECH SUBDURAL ELECTRODE	May 09, 1997	Substantially Equivalent	Ad-Tech Medical Instrument Corp
K964224	STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE	Mar 19, 1997	Substantially Equivalent	Pmt Corp.
K926424	CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON	Nov 19, 1993	Substantially Equivalent	Radionics, Inc.
K923330	THE WESTERN CORTICAL ELECTRODE ARRAY	Nov 09, 1993	Substantially Equivalent	University Hospital (London) Development Corp.
K924226	OJEMANN CORTICAL STIMULATOR	Apr 21, 1993	Substantially Equivalent	Radionics, Inc.
K923803	AD-TECH SUB DURAL ELECTRODEDS	Oct 23, 1992	Substantially Equivalent	Ad-Tech Medical Instrument Corp
K912760	AD-TECH EPIDURAL PEG ELECTRODE	Jan 15, 1992	Substantially Equivalent	Ad-Tech Medical Instrument Corp
K882053	NICOLET EPIDURAL SPINAL ELECTRODE	Oct 18, 1988	Substantially Equivalent	Nicolet Instrument Corp.
K850342	WYLER SUBDURAL STRIP ELECTRODE	Jul 30, 1985	Substantially Equivalent for Some Indications	Ad-Tech Medical Instrument Corp
K845035	ELECTRODE FOR NEUROLOGICAL SURGERY 2111	Jul 30, 1985	Substantially Equivalent for Some Indications	Progress Mankind Technology