510(k) Report

Devices descending from K102003

36 later devices reach Xpress Balloon Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+1K132297EM Sinus Dilation SystemMedtronic Xomed, Inc.20135—
+1K120280Relieva Seeker Balloon Sinuplasty SystemAcclarent, Inc.20122—
+1K121351Sinus Dilation SystemEntrigue Surgical, Inc.20128—
+1K112506Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201121—
+1K111875Relieva Spin Sinus Dilation SystemAcclarent, Inc.20117—
+1K111254Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc.20117—
+2K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+2K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+2K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—
+2K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+2K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+2K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.20150—
+2K143738DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC20150—
+2K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc.20152—
+2K140160Relieva Scout Sinus Dilation SystemAcclarent, Inc.20140—
+2K133016Vent-OS Sinus Dilation SystemSinusys Corporation20130—
+2K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp.20130—
+2K121174Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201220—
+3K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+3K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+3K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+3K121943Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201217—
+4K160770Vent-Os Sinus Dilation familySinusys Corporation20160—
+4K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201314—
+5K142252XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc.201413—
+6K152434XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc.201511—
+7K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+7K163509XprESS ENT Dilation SystemEntellus Medical, Inc.20179—
+8K220027Audion ET dilation systemEntellus Medical, Inc.20220—
+8K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+8K201398SINUSPRIME Dilation SystemStryker Ent20200—
+8K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+9K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+9K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+10K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—