510(k) Report

Devices descending from K034004

50 later devices reach Diego RF Powered Dissector and Drill System Console through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+1K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+1K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+1K121678DTADGyrus Acmi, Inc.20122—
+1K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080—
+1K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+2K102366Finess EndoscopeEntellus Medical, Inc.20110—
+2K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc.200842—
+3K102003Xpress Balloon DeviceEntellus Medical, Inc.201036—
+3K093007Entellus Medical Balloon DeviceEntellus Medical, Inc.201041—
+4K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+4K132297EM Sinus Dilation SystemMedtronic Xomed, Inc.20135—
+4K120280Relieva Seeker Balloon Sinuplasty SystemAcclarent, Inc.20122—
+4K121351Sinus Dilation SystemEntrigue Surgical, Inc.20128—
+4K112506Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201121—
+4K111875Relieva Spin Sinus Dilation SystemAcclarent, Inc.20117—
+4K111254Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc.20117—
+4K110158Illuminating Sinus SeekerEntellus Medical, Inc.20113—
+5K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+5K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+5K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—
+5K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+5K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+5K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.20150—
+5K143738DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC20150—
+5K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc.20152—
+5K140160Relieva Scout Sinus Dilation SystemAcclarent, Inc.20140—
+5K133016Vent-OS Sinus Dilation SystemSinusys Corporation20130—
+5K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp.20130—
+5K121174Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201220—
+5K113522Pathassist Light SeekerEntellus Medical, Inc.20122—
+6K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+6K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+6K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+6K121943Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201217—
+6K120735Pathassit Light SeekerEntellus Medical, Inc.20121—
+7K160770Vent-Os Sinus Dilation familySinusys Corporation20160—
+7K133563Pathassist Light SeekerEntellus Medical, Inc.20130—
+7K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201314—
+8K142252XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc.201413—
+9K152434XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc.201511—
+10K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+10K163509XprESS ENT Dilation SystemEntellus Medical, Inc.20179—
+11K220027Audion ET dilation systemEntellus Medical, Inc.20220—
+11K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+11K201398SINUSPRIME Dilation SystemStryker Ent20200—
+11K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+12K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+12K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+13K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—