510(k) Report

Devices descending from K000778

178 later devices reach Entec Reflex Wand 55, Model E4055-01, E4045-01 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K081954Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector CableGyrus Acmi, Inc.20080—
+5K071759LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand…Live Tissue Connect, Inc.20080—
+5K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc.200842—
+5K072865Modificaton to: Arthrocare ArthrowandsArthrocare Corp.200720—
+5K063538Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control…Arthrocare Corp.200640—
+5K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical20060—
+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
+6K222032NEUROMARK SystemNeurent Medical20222—
+6K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+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
+6K161825PK AIMGyrus Acmi, Inc.20162—
+6K142759PK Cutting Forceps for ESG-400 WorkstationGyrus Acmi, Inc.20152—
+6K102003Xpress Balloon DeviceEntellus Medical, Inc.201036—
+6K093007Entellus Medical Balloon DeviceEntellus Medical, Inc.201041—
+6K082323Arthrocare ArthrowandsArthrocare Corp.200819—
+7K250048NEUROMARK System (NMK00301)Neurent Medical, Ltd.20251—
+7K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+7K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH202114
+7K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+7K163373PK AIMGyrus Acmi, Inc.20161—
+7K132297EM Sinus Dilation SystemMedtronic Xomed, Inc.20135—
+7K120280Relieva Seeker Balloon Sinuplasty SystemAcclarent, Inc.20122—
+7K121351Sinus Dilation SystemEntrigue Surgical, Inc.20128—
+7K112506Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201121—
+7K111875Relieva Spin Sinus Dilation SystemAcclarent, Inc.20117—
+7K111254Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc.20117—
+7K110158Illuminating Sinus SeekerEntellus Medical, Inc.20113—
+7K083281EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction Ablator, Model…Linvatec Corp.20090—
+7K082980Arthrocare ArthrowandsArthrocare Corp.20081712
+8K261833NEUROMARK System (NMK00301)Neurent Medical, Ltd.20260—
+8K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+8K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+8K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—
+8K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+8K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+8K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.20150—
+8K143738DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC20150—
+8K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc.20152—
+8K140160Relieva Scout Sinus Dilation SystemAcclarent, Inc.20140—
+8K133016Vent-OS Sinus Dilation SystemSinusys Corporation20130—
+8K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp.20130—
+8K121174Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201220—
+8K113522Pathassist Light SeekerEntellus Medical, Inc.20122—
+8K090393Arthrocare System 15000 Contoller, Model 72202149, Arthrocare Arthrowands, Model…Arthrocare Corp.20091—
+8K083306Modification to Arthrocare ArthrowandsArthrocare Corp.2008141
+9K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+9K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+9K180848AMBIENT Super MULTIVAC 50 Wand with Integrated Finger SwitchesArthroCare Corporation20180—
+9K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+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—
+9K143235RF20000a Controller, FLOW 50 WandArthroCare Corporation20154—
+9K120791Ambient Turboflash 90 IfsArthocare Corporation20124—
+9K121943Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201217—
+9K120735Pathassit Light SeekerEntellus Medical, Inc.20121—
+9K093165Arthrocare System 15000 Controller, ArthrowandsArthrocare Corp.20090—
+10K162074Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation20163—
+10K160770Vent-Os Sinus Dilation familySinusys Corporation20160—
+10K133563Pathassist Light SeekerEntellus Medical, Inc.20130—
+10K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201314—
+11K183346FLOW 90 WandArthroCare Corporation20192—
+11K142252XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc.201413—
+12K240964FLOW 90? WandArthroCare Corporation20241—
+12K152434XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc.201511—
+13K254122FLOW FLEXTEND Wand (72290039)ArthroCare Corporation20260—
+13K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+13K163509XprESS ENT Dilation SystemEntellus Medical, Inc.20179—
+14K220027Audion ET dilation systemEntellus Medical, Inc.20220—
+14K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+14K201398SINUSPRIME Dilation SystemStryker Ent20200—
+14K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+15K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+15K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+16K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—