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FDA 510(k)

iCE-SG Subcutaneous Electrode Arrays

K-Number: K201678 · 2021-03-08

ApplicantIce Neurosystems, Inc.
Decision Date2021-03-08
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

iCE-SG Subcutaneous Electrode Arrays is a medical device manufactured by Ice Neurosystems, Inc.. It received FDA 510(k) clearance on 2021-03-08 under approval number K201678. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iCE-SG Subcutaneous Electrode Arrays?

iCE-SG Subcutaneous Electrode Arrays is a medical device that received FDA 510(k) clearance on 2021-03-08. It is manufactured by Ice Neurosystems, Inc.. The 510(k) number is K201678.

When was iCE-SG Subcutaneous Electrode Arrays approved by the FDA?

iCE-SG Subcutaneous Electrode Arrays received FDA 510(k) clearance on 2021-03-08, under approval number K201678.

What company makes iCE-SG Subcutaneous Electrode Arrays?

iCE-SG Subcutaneous Electrode Arrays is manufactured by Ice Neurosystems, Inc..

What is the FDA product code for iCE-SG Subcutaneous Electrode Arrays?

The FDA product code for iCE-SG Subcutaneous Electrode Arrays is GZL.

Related Clinical Trials

NCT05505513 Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Feedback? RECRUITING

Other Devices by Ice Neurosystems, Inc.

K191868iCEWav Neuromonitoring Platform K222706iCE-SG2 Subcutaneous Electrode Kit

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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