Electrocore, 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
gammaCore Sapphire510(k)Sep 10, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Sep 10, 2021
gammaCore Sapphire510(k)Feb 12, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Feb 12, 2021