510(k) Report

Devices descending from K081542

42 later devices reach Modification to Entellus Medical RS-Series System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102003Xpress Balloon DeviceEntellus Medical, Inc.201036—
+1K093007Entellus Medical Balloon DeviceEntellus Medical, Inc.201041—
+2K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+2K132297EM Sinus Dilation SystemMedtronic Xomed, Inc.20135—
+2K120280Relieva Seeker Balloon Sinuplasty SystemAcclarent, Inc.20122—
+2K121351Sinus Dilation SystemEntrigue Surgical, Inc.20128—
+2K112506Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201121—
+2K111875Relieva Spin Sinus Dilation SystemAcclarent, Inc.20117—
+2K111254Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc.20117—
+2K110158Illuminating Sinus SeekerEntellus Medical, Inc.20113—
+3K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+3K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+3K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—
+3K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+3K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+3K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.20150—
+3K143738DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC20150—
+3K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc.20152—
+3K140160Relieva Scout Sinus Dilation SystemAcclarent, Inc.20140—
+3K133016Vent-OS Sinus Dilation SystemSinusys Corporation20130—
+3K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp.20130—
+3K121174Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201220—
+3K113522Pathassist Light SeekerEntellus Medical, Inc.20122—
+4K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+4K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+4K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+4K121943Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201217—
+4K120735Pathassit Light SeekerEntellus Medical, Inc.20121—
+5K160770Vent-Os Sinus Dilation familySinusys Corporation20160—
+5K133563Pathassist Light SeekerEntellus Medical, Inc.20130—
+5K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201314—
+6K142252XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc.201413—
+7K152434XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc.201511—
+8K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+8K163509XprESS ENT Dilation SystemEntellus Medical, Inc.20179—
+9K220027Audion ET dilation systemEntellus Medical, Inc.20220—
+9K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+9K201398SINUSPRIME Dilation SystemStryker Ent20200—
+9K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+10K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+10K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+11K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—