510(k) Report

Devices descending from K981361

136 later devices reach Powerstar Bipolar Scissors through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K112506Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201121—
+7K111875Relieva Spin Sinus Dilation SystemAcclarent, Inc.20117—
+7K111254Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc.20117—
+7K110158Illuminating Sinus SeekerEntellus Medical, Inc.20113—
+8K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+8K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+8K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—
+8K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+8K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+8K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.20150—
+8K143738DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC20150—
+8K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc.20152—
+8K140160Relieva Scout Sinus Dilation SystemAcclarent, Inc.20140—
+8K133016Vent-OS Sinus Dilation SystemSinusys Corporation20130—
+8K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp.20130—
+8K121174Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201220—
+8K113522Pathassist Light SeekerEntellus Medical, Inc.20122—
+9K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+9K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+9K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+9K121943Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201217—
+9K120735Pathassit Light SeekerEntellus Medical, Inc.20121—
+10K160770Vent-Os Sinus Dilation familySinusys Corporation20160—
+10K133563Pathassist Light SeekerEntellus Medical, Inc.20130—
+10K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201314—
+11K142252XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc.201413—
+12K152434XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc.201511—
+13K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+13K163509XprESS ENT Dilation SystemEntellus Medical, Inc.20179—
+14K220027Audion ET dilation systemEntellus Medical, Inc.20220—
+14K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+14K201398SINUSPRIME Dilation SystemStryker Ent20200—
+14K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+15K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+15K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+16K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—