Ice Neurosystems, Inc. FDA Approvals

0 new drug approvals and 2 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
iCE-SG2 Subcutaneous Electrode Kit510(k)Dec 6, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Dec 6, 2022
iCE-SG Subcutaneous Electrode Arrays510(k)Mar 8, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Mar 8, 2021