DIXI Medical Microdeep Depth Electrode

FDA 510(k) K170959 · Dixi Medical

Substantially Equivalent

510(k) numberK170959

Submission

Device name
DIXI Medical Microdeep Depth Electrode
Applicant
Dixi Medical
Chaudefontaine, FR
Received
March 31, 2017
Decision date
November 24, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GZL – Electrode, Depth
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1330
Specialty
Neurology

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K223276Anchor Bolts as Accessories to Depth ElectrodesGZL · Traditional Ad-Tech Medical Instrument Corporation05/18/2023SE
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K213170SENSOSEEG Depth ElectrodesGZL · Traditional Sensomedical Labs, Ltd.04/18/2023SE
K222706iCE-SG2 Subcutaneous Electrode KitGZL · Traditional Ice Neurosystems, Inc.12/06/2022SE
K222404Evo® sEEG SystemGZL · Traditional Neuroone Medical Technologies Corp.10/20/2022SE
K220553Neuro Omega System, NeuroSmart SystemGZL · Special Alpha Omega Engineering , Ltd.09/16/2022SE
K202087DIXI Medical Microdeep Micro-Macro Depth ElectrodesGZL · Traditional Dixi Medical11/18/2021SE

More from Dixi Medical

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K202087DIXI Medical Microdeep Micro-Macro Depth ElectrodesGZL · Traditional 11/18/2021SE
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Questions and answers

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

DIXI Medical Microdeep Depth Electrode (K170959) received a 510(k) decision of Substantially Equivalent on November 24, 2017, 238 days after the submission was received.

What is the product code of K170959?

The FDA product code is GZL – Electrode, Depth, a Class II (moderate risk) device regulated under 21 CFR 882.1330.