510(k) Report

Devices descending from K012314

52 later devices reach Dyonics Electroblade Resector through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041328Smith & Nephew Electroblade Resector/AdaptorSmith & Nephew, Inc.20040—
+1K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC200450—
+2K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+2K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+2K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+2K121678DTADGyrus Acmi, Inc.20122—
+2K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080—
+2K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+3K102366Finess EndoscopeEntellus Medical, Inc.20110—
+3K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc.200842—
+4K102003Xpress Balloon DeviceEntellus Medical, Inc.201036—
+4K093007Entellus Medical Balloon DeviceEntellus Medical, Inc.201041—
+5K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+5K132297EM Sinus Dilation SystemMedtronic Xomed, Inc.20135—
+5K120280Relieva Seeker Balloon Sinuplasty SystemAcclarent, Inc.20122—
+5K121351Sinus Dilation SystemEntrigue Surgical, Inc.20128—
+5K112506Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201121—
+5K111875Relieva Spin Sinus Dilation SystemAcclarent, Inc.20117—
+5K111254Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc.20117—
+5K110158Illuminating Sinus SeekerEntellus Medical, Inc.20113—
+6K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+6K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+6K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—
+6K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+6K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+6K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.20150—
+6K143738DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC20150—
+6K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc.20152—
+6K140160Relieva Scout Sinus Dilation SystemAcclarent, Inc.20140—
+6K133016Vent-OS Sinus Dilation SystemSinusys Corporation20130—
+6K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp.20130—
+6K121174Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201220—
+6K113522Pathassist Light SeekerEntellus Medical, Inc.20122—
+7K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+7K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+7K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+7K121943Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201217—
+7K120735Pathassit Light SeekerEntellus Medical, Inc.20121—
+8K160770Vent-Os Sinus Dilation familySinusys Corporation20160—
+8K133563Pathassist Light SeekerEntellus Medical, Inc.20130—
+8K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201314—
+9K142252XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc.201413—
+10K152434XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc.201511—
+11K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+11K163509XprESS ENT Dilation SystemEntellus Medical, Inc.20179—
+12K220027Audion ET dilation systemEntellus Medical, Inc.20220—
+12K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+12K201398SINUSPRIME Dilation SystemStryker Ent20200—
+12K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+13K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+13K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+14K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—