Cleared Traditional

K202087 - DIXI Medical Microdeep Micro-Macro Depth Electrodes (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202087 · Dixi Medical · Neurology device
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Nov 2021
Decision
478d
Days
Class 2
Risk

K202087 is an FDA 510(k) clearance for the DIXI Medical Microdeep Micro-Macro Depth Electrodes. 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 18, 2021 after a review of 478 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Dixi Medical devices

Submission Details

510(k) Number K202087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2020
Decision Date November 18, 2021
Days to Decision 478 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
330d slower than avg
Panel avg: 148d · This submission: 478d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

Regulatory Consultant

Domecus Consulting Services, LLC
Steve Plymale

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GZL Electrode, Depth

All 57
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K202087.
Wovyn Depth Electrode
K253970 · Sensomedical Labs, Ltd. · Apr 2026
Depth Electrode (RSDE-08)
K250363 · Beijing Sinovation Medical Technology Co., Ltd. · Nov 2025
Neuro Omega System
K250601 · Alpha Omega Engineering , Ltd. · Mar 2025
Spencer Probe Depth Electrodes
K223269 · Ad-Tech Medical Instrument Corporation · May 2023
Anchor Bolts as Accessories to Depth Electrodes
K223276 · Ad-Tech Medical Instrument Corporation · May 2023
SENSOSEEG Depth Electrodes
K213170 · Sensomedical Labs, Ltd. · Apr 2023