510(k) Report

Devices descending from K112506

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+1K121174Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201220—
+2K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+2K121943Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201217—
+3K160770Vent-Os Sinus Dilation familySinusys Corporation20160—
+3K133016Vent-OS Sinus Dilation SystemSinusys Corporation20130—
+3K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201314—
+4K142252XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc.201413—
+5K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+5K152434XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc.201511—
+6K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+6K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+6K163509XprESS ENT Dilation SystemEntellus Medical, Inc.20179—
+7K220027Audion ET dilation systemEntellus Medical, Inc.20220—
+7K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+7K201398SINUSPRIME Dilation SystemStryker Ent20200—
+7K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+8K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+8K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+8K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+9K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—