510(k) Report

Devices descending from K011279

176 later devices reach Entec Evac Plasma Wand through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K063538Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control…Arthrocare Corp.200640—
+5K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical20060—
+5K033584Arthrocare ArthrowandsArthrocare Corp.2003431
+6K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+6K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+6K251899E BlatorNew Deantronics Taiwan, Ltd.20250—
+6K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+6K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH202114
+6K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+6K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+6K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc.20180—
+6K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+6K163373PK AIMGyrus Acmi, Inc.20161—
+6K153675Paragon T2 Wand with Integrated CableArthroCare Corporation20160—
+6K140521Topaz EZ Microdebrider Coblation Wand with Integrated Finger SwitchArthroCare Corporation20140—
+6K132297EM Sinus Dilation SystemMedtronic Xomed, Inc.20135—
+6K120280Relieva Seeker Balloon Sinuplasty SystemAcclarent, Inc.20122—
+6K121351Sinus Dilation SystemEntrigue Surgical, Inc.20128—
+6K112506Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201121—
+6K111875Relieva Spin Sinus Dilation SystemAcclarent, Inc.20117—
+6K111254Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc.20117—
+6K110158Illuminating Sinus SeekerEntellus Medical, Inc.20113—
+6K093165Arthrocare System 15000 Controller, ArthrowandsArthrocare Corp.20090—
+6K082666Arthrocare Controller (System 12000), Arthrocare Patient Cable, Foot Control, Power…Arthrocare Corp.200812—
+6K072865Modificaton to: Arthrocare ArthrowandsArthrocare Corp.200720—
+7K220563Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System…ArthroCare Corporation20221—
+7K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+7K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+7K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+7K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—
+7K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+7K161581Arthrex Synergy RF SystemArthrex, Inc.20160—
+7K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+7K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.20150—
+7K143235RF20000a Controller, FLOW 50 WandArthroCare Corporation20154—
+7K143738DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC20150—
+7K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc.20152—
+7K140578Arthroscopic Energy SystemConmed Corporation201411
+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—
+7K082323Arthrocare ArthrowandsArthrocare Corp.200819—
+8K242907DELPHI SystemCnS Medical Co., Ltd.20250—
+8K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+8K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+8K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+8K162074Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation20163—
+8K153499EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy…Conmed Corporation20150—
+8K121943Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201217—
+8K120735Pathassit Light SeekerEntellus Medical, Inc.20121—
+8K083281EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction Ablator, Model…Linvatec Corp.20090—
+8K082980Arthrocare ArthrowandsArthrocare Corp.20081712
+9K183346FLOW 90 WandArthroCare Corporation20192—
+9K160770Vent-Os Sinus Dilation familySinusys Corporation20160—
+9K133563Pathassist Light SeekerEntellus Medical, Inc.20130—
+9K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201314—
+9K083306Modification to Arthrocare ArthrowandsArthrocare Corp.2008141
+10K240964FLOW 90? WandArthroCare Corporation20241—
+10K180848AMBIENT Super MULTIVAC 50 Wand with Integrated Finger SwitchesArthroCare Corporation20180—
+10K171324Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew DyonicsSurgical Instrument Service and Savings, Inc.20170—
+10K162126Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated…ArthroCare Corporation20160—
+10K142252XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc.201413—
+10K120791Ambient Turboflash 90 IfsArthocare Corporation20124—
+11K254122FLOW FLEXTEND Wand (72290039)ArthroCare Corporation20260—
+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—