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FDA 510(k)

Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)

K-Number: K201931 · 2021-10-02

ApplicantDixi Medical
Decision Date2021-10-02
Product CodeGYC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) is the device name listed in this FDA 510(k) record. The listed applicant is Dixi Medical. It received FDA 510(k) clearance on 2021-10-02 under 510(k) number K201931. 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 Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)?

Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) is a medical device that received FDA 510(k) clearance on 2021-10-02. The listed applicant is Dixi Medical. The 510(k) number is K201931.

When did Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) receive FDA 510(k) clearance?

Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) received FDA 510(k) clearance on 2021-10-02, under 510(k) number K201931.

Who is the listed applicant for Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)?

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

What is the FDA product code for Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)?

The FDA product code for Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) is GYC.

Other records listing Dixi Medical as applicant

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.

K202087DIXI Medical Microdeep Micro-Macro Depth ElectrodesK170959DIXI Medical Microdeep Depth Electrode

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 SrlK191346Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)Blackrock MicrosystemsK191186Subdural 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

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

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