Cleared Traditional

K222706 - iCE-SG2 Subcutaneous Electrode Kit (FDA 510(k) Clearance)

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

K222706 · Ice Neurosystems, Inc. · Neurology device
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Dec 2022
Decision
90d
Days
Class 2
Risk

K222706 is an FDA 510(k) clearance for the iCE-SG2 Subcutaneous Electrode Kit. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Ice Neurosystems, Inc. (Washington, US). The FDA issued a Cleared decision on December 6, 2022 after a review of 90 days - within the typical 510(k) review window.

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.

View all Ice Neurosystems, Inc. devices

Submission Details

510(k) Number K222706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2022
Decision Date December 06, 2022
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
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

RQM+
Allison Komiyama

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 K222706.
Wovyn Depth Electrode
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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
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SENSOSEEG Depth Electrodes
K213170 · Sensomedical Labs, Ltd. · Apr 2023