510(k) Report

Devices descending from K013463

134 later devices reach Arthrocare Arthro Wands, Enetec Evac Plasma Wand through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K140160Relieva Scout Sinus Dilation SystemAcclarent, Inc.20140—
+7K133016Vent-OS Sinus Dilation SystemSinusys Corporation20130—
+7K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp.20130—
+7K121174Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201220—
+7K113522Pathassist Light SeekerEntellus Medical, Inc.20122—
+7K083281EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction Ablator, Model…Linvatec Corp.20090—
+7K082980Arthrocare ArthrowandsArthrocare Corp.20081712
+8K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+8K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+8K183346FLOW 90 WandArthroCare Corporation20192—
+8K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+8K121943Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201217—
+8K120735Pathassit Light SeekerEntellus Medical, Inc.20121—
+8K083306Modification to Arthrocare ArthrowandsArthrocare Corp.2008141
+9K240964FLOW 90? WandArthroCare Corporation20241—
+9K180848AMBIENT Super MULTIVAC 50 Wand with Integrated Finger SwitchesArthroCare Corporation20180—
+9K171324Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew DyonicsSurgical Instrument Service and Savings, Inc.20170—
+9K162126Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated…ArthroCare Corporation20160—
+9K160770Vent-Os Sinus Dilation familySinusys Corporation20160—
+9K133563Pathassist Light SeekerEntellus Medical, Inc.20130—
+9K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201314—
+9K120791Ambient Turboflash 90 IfsArthocare Corporation20124—
+10K254122FLOW FLEXTEND Wand (72290039)ArthroCare Corporation20260—
+10K142252XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc.201413—
+11K152434XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc.201511—
+12K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+12K163509XprESS ENT Dilation SystemEntellus Medical, Inc.20179—
+13K220027Audion ET dilation systemEntellus Medical, Inc.20220—
+13K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+13K201398SINUSPRIME Dilation SystemStryker Ent20200—
+13K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+14K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+14K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+15K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—