Insight Medical Systems, 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
ARVIS® Shoulder510(k)Apr 29, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Apr 29, 2024
ARVIS Surgical Navigation System510(k)Jul 14, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 14, 2021