510(k) Report

Devices descending from K152434

11 later devices reach XprESS Multi-Sinus Dilation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+1K163509XprESS ENT Dilation SystemEntellus Medical, Inc.20179—
+2K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+2K220027Audion ET dilation systemEntellus Medical, Inc.20220—
+2K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+2K201398SINUSPRIME Dilation SystemStryker Ent20200—
+2K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+3K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+3K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+3K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+4K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—