Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AirRay Subdural Cortical Electrodes

K-Number: K183437 · 2019-03-12

ApplicantCortec GmbH
Decision Date2019-03-12
Product CodeGYC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AirRay Subdural Cortical Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Cortec GmbH. It received FDA 510(k) clearance on 2019-03-12 under 510(k) number K183437. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AirRay Subdural Cortical Electrodes?

AirRay Subdural Cortical Electrodes is a medical device that received FDA 510(k) clearance on 2019-03-12. The listed applicant is Cortec GmbH. The 510(k) number is K183437.

When did AirRay Subdural Cortical Electrodes receive FDA 510(k) clearance?

AirRay Subdural Cortical Electrodes received FDA 510(k) clearance on 2019-03-12, under 510(k) number K183437.

Who is the listed applicant for AirRay Subdural Cortical Electrodes?

The FDA 510(k) record lists Cortec GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AirRay Subdural Cortical Electrodes?

The FDA product code for AirRay Subdural Cortical Electrodes is GYC.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06252532Causal Role of Top-Down Theta Oscillations in PrioritizationENROLLING_BY_INVITATIONNCT07698496Evaluation of the Feasibility and Efficacy of a Chronic Brain-computer Interface for Speech Rehabilitation in Patients With Locked-in-syndrome (LIS)NOT_YET_RECRUITING

Related Devices (Code: GYC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250094Atlas 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)Neuralynx, Inc.K242618Layer 7-TPrecision Neuroscience, Corp.K221123WISE Cortical Strip (WCS)Wise S.R.L.K211954Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping GridSpes Medica SrlK201931Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)Dixi MedicalK191346Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)Blackrock Microsystems

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑