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FDA 510(k)

DIXI Medical Microdeep Micro-Macro Depth Electrodes

K-Number: K202087 · 2021-11-18

ApplicantDixi Medical
Decision Date2021-11-18
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DIXI Medical Microdeep Micro-Macro Depth Electrodes is a medical device manufactured by Dixi Medical. It received FDA 510(k) clearance on 2021-11-18 under approval number K202087. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIXI Medical Microdeep Micro-Macro Depth Electrodes?

DIXI Medical Microdeep Micro-Macro Depth Electrodes is a medical device that received FDA 510(k) clearance on 2021-11-18. It is manufactured by Dixi Medical. The 510(k) number is K202087.

When was DIXI Medical Microdeep Micro-Macro Depth Electrodes approved by the FDA?

DIXI Medical Microdeep Micro-Macro Depth Electrodes received FDA 510(k) clearance on 2021-11-18, under approval number K202087.

What company makes DIXI Medical Microdeep Micro-Macro Depth Electrodes?

DIXI Medical Microdeep Micro-Macro Depth Electrodes is manufactured by Dixi Medical.

What is the FDA product code for DIXI Medical Microdeep Micro-Macro Depth Electrodes?

The FDA product code for DIXI Medical Microdeep Micro-Macro Depth Electrodes is GZL.

Related Clinical Trials

NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT05664854 Electrical Impedance Tomography & Selective Stimulation of Vagus Nerve RECRUITING NCT01900132 Electrical Impedance Myography: Natural History Studies inNeuromuscular Disorders and Healthy Volunteers RECRUITING NCT05505513 Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Feedback? RECRUITING NCT07580066 Cerebellum and Neglect NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41573697 Conformity Assessment of Medical Devices: An Overview from a Notified Body. Journal of market access & health policy (2026)

Other Devices by Dixi Medical

K170959DIXI Medical Microdeep Depth Electrode K201931Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)

Related Devices (Code: GZL)

K151790PMT Platinum Depthalon Depth ElectrodePmt Corporation K152547DNAP ElectrodeAd-Tech Medical Instrument Corporation K171581Neuro Omega SystemAlpha Omega Engineering , Ltd. K170959DIXI Medical Microdeep Depth ElectrodeDixi Medical K162459AccuPoint ElectrodeMicroprobes For Life Science, Inc. Dba Neuron K163355Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth ElectrodesAd-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.

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