iCE-SG2 Subcutaneous Electrode Kit

FDA 510(k) K222706 · Ice Neurosystems, Inc.

Substantially Equivalent

510(k) numberK222706

Submission

Device name
iCE-SG2 Subcutaneous Electrode Kit
Applicant
Ice Neurosystems, Inc.
Washington, DC, US
Received
September 7, 2022
Decision date
December 6, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GZL – Electrode, Depth
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1330
Specialty
Neurology

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Questions and answers

When was iCE-SG2 Subcutaneous Electrode Kit cleared by the FDA?

iCE-SG2 Subcutaneous Electrode Kit (K222706) received a 510(k) decision of Substantially Equivalent on December 6, 2022, 90 days after the submission was received.

What is the product code of K222706?

The FDA product code is GZL – Electrode, Depth, a Class II (moderate risk) device regulated under 21 CFR 882.1330.