Cleared Traditional

K170959 - DIXI Medical Microdeep Depth Electrode

K170959 is an FDA 510(k) clearance for DIXI Medical Microdeep Depth Electrode, manufactured by Dixi Medical. The device is a Class 2 Neurology device with product code GZL cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K170959 · Dixi Medical · Neurology device
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Nov 2017
Decision
238d
Days
Class 2
Risk

K170959 is an FDA 510(k) clearance for the DIXI Medical Microdeep Depth Electrode. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Dixi Medical (Chaudefontaine, FR). The FDA issued a Cleared decision on November 24, 2017 after a review of 238 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1330 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K170959

510(k) Number K170959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2017
Decision Date November 24, 2017
Days to Decision 238 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 148d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZL Device Classification - Class 2, Special Controls

Product Code GZL Electrode, Depth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.