FDA 510(k)

DIXI Medical Microdeep Depth Electrode

K-Number: K170959 · 2017-11-24

Decision Date2017-11-24

Product CodeGZL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

DIXI Medical Microdeep Depth Electrode is a medical device manufactured by Dixi Medical. It received FDA 510(k) clearance on 2017-11-24 under approval number K170959. 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 Depth Electrode?

DIXI Medical Microdeep Depth Electrode is a medical device that received FDA 510(k) clearance on 2017-11-24. It is manufactured by Dixi Medical. The 510(k) number is K170959.

When was DIXI Medical Microdeep Depth Electrode approved by the FDA?

DIXI Medical Microdeep Depth Electrode received FDA 510(k) clearance on 2017-11-24, under approval number K170959.

What company makes DIXI Medical Microdeep Depth Electrode?

DIXI Medical Microdeep Depth Electrode is manufactured by Dixi Medical.

What is the FDA product code for DIXI Medical Microdeep Depth Electrode?

The FDA product code for DIXI Medical Microdeep Depth Electrode is GZL.

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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

K202087DIXI Medical Microdeep Micro-Macro Depth Electrodes K201931Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)

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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.