Acclarent, Inc. 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
Acclarent AERA Eustachian Tube Balloon Dilation System510(k)Feb 19, 2026Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Feb 19, 2026
ACCLARENT AERA Eustachian Tube Dilation System510(k)Dec 13, 2023Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Dec 13, 2023
TruDi® Navigation System V3 (FG-2000-00)510(k)Jul 21, 2023Neurology	Neurology	510(k)Substantially Equivalent (Special)	Jul 21, 2023
TruDi Shaver Blade510(k)Jul 20, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 20, 2022