Spark Biomedical, Inc. FDA Approvals

0 new drug approvals and 3 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
Sparrow Ascent510(k)Aug 25, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Aug 25, 2025
Sparrow Ascent510(k)Jun 20, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jun 20, 2023
Sparrow Therapy System510(k)Jan 2, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jan 2, 2021