Clarus Medical, LLC FDA Approvals

0 new drug approvals and 4 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
Digital ClarusScope System and Digital NeuroPEN System510(k)May 26, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 26, 2026
Digital ClarusScope System; Digital NeuroPEN System510(k)Apr 25, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 25, 2024
Digital ClarusScope System, Digital NeuroPEN System510(k)Nov 21, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Nov 21, 2023
Clarus Peel-Away Introducer Sheath510(k)Mar 18, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Mar 18, 2021