510(k) Report

Devices descending from K132440

14 later devices reach Xpress Multi-Sinus Dilation Tool through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142252XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc.201413—
+2K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+2K152434XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc.201511—
+3K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+3K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+3K163509XprESS ENT Dilation SystemEntellus Medical, Inc.20179—
+4K220027Audion ET dilation systemEntellus Medical, Inc.20220—
+4K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+4K201398SINUSPRIME Dilation SystemStryker Ent20200—
+4K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+5K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+5K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+5K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+6K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—