Cleared Traditional

K201678 - iCE-SG Subcutaneous Electrode Arrays (FDA 510(k) Clearance)

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

K201678 · Ice Neurosystems, Inc. · Neurology device
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Mar 2021
Decision
262d
Days
Class 2
Risk

K201678 is an FDA 510(k) clearance for the iCE-SG Subcutaneous Electrode Arrays. 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 March 8, 2021 after a review of 262 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.

View all Ice Neurosystems, Inc. devices

Submission Details

510(k) Number K201678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2020
Decision Date March 08, 2021
Days to Decision 262 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
114d slower than avg
Panel avg: 148d · This submission: 262d
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

Acknowledge Regulatory Strategies, LLC
Allison C 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 K201678.
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Anchor Bolts as Accessories to Depth Electrodes
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SENSOSEEG Depth Electrodes
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