Cleared Traditional

K222706 - iCE-SG2 Subcutaneous Electrode Kit

K222706 is an FDA 510(k) clearance for iCE-SG2 Subcutaneous Electrode Kit, manufactured by Ice Neurosystems, Inc.. The device is a Class 2 Neurology device with product code GZL cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K222706

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.

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.

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 16
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K222706.
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