510(k) Report

Devices descending from K163509

9 later devices reach XprESS ENT Dilation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+1K220027Audion ET dilation systemEntellus Medical, Inc.20220—
+1K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+1K201398SINUSPRIME Dilation SystemStryker Ent20200—
+1K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+2K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+2K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+2K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+3K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—