Cleared Traditional

iCE-SG2 Subcutaneous Electrode Kit

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

About This 510(k) Submission

K222706 is an FDA 510(k) clearance for the iCE-SG2 Subcutaneous Electrode Kit, a Electrode, Depth (Class II — Special Controls, product code GZL), submitted by Ice Neurosystems, Inc. (Washington, US). The FDA issued a Cleared decision on December 6, 2022, 90 days after receiving the submission on September 7, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1330.

Submission Details

510(k) Number K222706 FDA.gov
FDA Decision Cleared 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

Device Classification

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

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