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

FDA 510(k)

NeuroOne Cortical Electrode

K-Number: K192764 · 2019-11-26

ApplicantNeuroone, Inc.
Decision Date2019-11-26
Product CodeGYC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NeuroOne Cortical Electrode is a medical device manufactured by Neuroone, Inc.. It received FDA 510(k) clearance on 2019-11-26 under approval number K192764. 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 NeuroOne Cortical Electrode?

NeuroOne Cortical Electrode is a medical device that received FDA 510(k) clearance on 2019-11-26. It is manufactured by Neuroone, Inc.. The 510(k) number is K192764.

When was NeuroOne Cortical Electrode approved by the FDA?

NeuroOne Cortical Electrode received FDA 510(k) clearance on 2019-11-26, under approval number K192764.

What company makes NeuroOne Cortical Electrode?

NeuroOne Cortical Electrode is manufactured by Neuroone, Inc..

What is the FDA product code for NeuroOne Cortical Electrode?

The FDA product code for NeuroOne Cortical Electrode is GYC.

Related Clinical Trials

NCT04958096 Cortical Stimulation to Treat Obsessive Compulsive Disorder RECRUITING NCT07543406 MINDZ-- Minimally Invasive Approach Pilot Study NOT_YET_RECRUITING NCT05393622 Brain Stimulation for Severe Depression RECRUITING

Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022)

Related Devices (Code: GYC)

K151354Cervello STIMBlackrock Neuromed K180761SD LTM STIM Cortical StimulatorMicromed S.P.A. K173684g.Estim PROG.Tec Medical Engineering GmbH K183437AirRay Subdural Cortical ElectrodesCortec GmbH K191346Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)Blackrock Microsystems K191186Subdural 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 ElectrodeAd-Tech Medical Instrument Corporation

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.

↑