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 the device name listed in this FDA 510(k) record. The listed applicant is Dixi Medical. It received FDA 510(k) clearance on 2017-11-24 under 510(k) 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. The listed applicant is Dixi Medical. The 510(k) number is K170959.

When did DIXI Medical Microdeep Depth Electrode receive FDA 510(k) clearance?

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

Who is the listed applicant for DIXI Medical Microdeep Depth Electrode?

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 Microdeep Depth Electrode?

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

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 Electrodes K201931Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)

Related Devices (Code: GZL)

Official Source

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