Cleared Traditional

K201678 - iCE-SG Subcutaneous Electrode Arrays

K201678 is an FDA 510(k) clearance for iCE-SG Subcutaneous Electrode Arrays, 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 262-day FDA review.

K201678 · Ice Neurosystems, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K201678

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.

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

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 16
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K201678.
Neuro Omega System, NeuroSmart System
K220553 · Alpha Omega Engineering , Ltd. · Sep 2022
DIXI Medical Microdeep Micro-Macro Depth Electrodes
K202087 · Dixi Medical · Nov 2021
Evo sEEG System
K211367 · Neuroone Medical Technologies Corp. · Sep 2021
Sterile LeadConfirm
K191739 · Alpha Omega Engineering , Ltd. · Jan 2020
microTargeting Guideline 4000 5.0 System
K183123 · FHC, Inc. · Dec 2018
Anchor Bolt (as an accessory to Depth Electrodes)
K181544 · Ad-Tech Medical Instrument Corporation · Aug 2018