Cleared Traditional

iCE-SG Subcutaneous Electrode Arrays

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

About This 510(k) Submission

K201678 is an FDA 510(k) clearance for the iCE-SG Subcutaneous Electrode Arrays, a Electrode, Depth (Class II — Special Controls, product code GZL), submitted by Ice Neurosystems, Inc. (Washington, US). The FDA issued a Cleared decision on March 8, 2021, 262 days after receiving the submission on June 19, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1330.

Submission Details

510(k) Number K201678 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code GZL — Electrode, Depth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1330

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