510(k) Report

Devices descending from K000036

125 later devices reach Entec Reflex Wand 55, Model E4055-00 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032838Celon Ent SystemCelon AG Medical Instruments20033—
+1K014290Entec Plasma WandsArthrocare Corp.2002119—
+1K012631Reprocessed Soft Tissue AblatorsAlliance Medical Corp.20011—
+2K252043Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus…Olympus Winter & Ibe GmbH20250—
+2K191732Sutter RaVoR Bipolar ElectrodesSutter Medizintechnik GmbH20190—
+2K152703PlasmaBlade TnA Tonsil and Adenoid Dissection DeviceMedtronic Advanced Energy20160—
+2K160639Electrosurgical Generator ESG-200Olympus Winter & Ibe GmbH20160—
+2K150297PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy20150—
+2K123353Ciq Controller, Ciq WandsArthroCare Corporation20130—
+2K100543Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss201001
+2K070374Arthrocare Ent Plasma WandArthrocare Corp.2007391
+2K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical20060—
+2K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC200276—
+2K021364Modification to Entec Plasma WandsArthrocare Corp.200294—
+3K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter…ArthroCare Corporation20202—
+3K192027WEREWOLF COBLATION System, COBLATION HALO WandArthroCare Corporation20193—
+3K172647Reprocessed ArthroCare ENT CoblatorRenovo, Inc.20180—
+3K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated…ArthroCare Corporation201443
+3K122652Arthrocare Turbinator WandArthroCare Corporation20133—
+3K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+3K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.20098—
+3K041633Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc.20048—
+3K041285Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision…Gyrus Medical, Ltd.2004202
+3K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC200450—
+3K030033Lumenis Family of Disposable Contact Tip Delivery DevicesLumenis, Ltd.20030—
+3K030108Arthrocare Ent Coblator Surgery SystemArthrocare Corp.2003921
+4K253680LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation20260—
+4K251996ENTire IRE SystemEntire Medical, Ltd.20261—
+4K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System…ArthroCare Corporation20230—
+4K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+4K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+4K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+4K152702Ent Biotech Solutions Tissue Removal Device (Elasso)Ent Biotech Solutions20160—
+4K142289PK SpatulaGyrus Acmi, Inc.20141—
+4K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+4K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+4K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+4K121678DTADGyrus Acmi, Inc.20122—
+4K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+4K103775Peak Suction CoagulatorPeak Surgical, Inc.20111—
+4K102709Peak Plasmablade Plus Tissue Dissection DevicePeak Surgical, Inc.20100—
+4K091674Arthrocare Coblator IQ SystemArthrocare Corp.20101—
+4K080844G3 Generator and Accessories-Dissector Plasma KnifeGyrus Acmi, Inc.20091—
+4K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080—
+4K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc.20081—
+4K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+4K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.200514—
+4K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc.20056—
+4K033257Arthrocare Ent Plasma WandsArthrocare Corp.200342—
+5K261202ENTire IRE SystemEntire Medical, Ltd.20260—
+5K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc.20220—
+5K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+5K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+5K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+5K170908PK AIMGyrus Acmi, Inc.20170—
+5K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions201701
+5K161038PK MorcellatorGyrus Acmi, Inc.20160—
+5K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC20164—
+5K150524Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings, Inc.20150—
+5K151340HARMONIC Focus Long Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20150—
+5K142350PK J-HookGyrus Acmi, Inc.201511
+5K142525PK Lap LoopOlympus Winter & Ibe GmbH20140—
+5K131205Arthrocare Head and Neck Coblation WandArthroCare Corporation20130—
+5K130305Lina Bipolar Loop; Standard Size, Large Size, Extra Large SizeLina Medical Aps20130—
+5K122605PKS BillGyrus Acmi, Inc.20121—
+5K102366Finess EndoscopeEntellus Medical, Inc.20110—
+5K100896Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc.201031
+5K081766PKS Omni InstrumentGyrus-Acmi L.P.200831
+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—
+5K063538Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control…Arthrocare Corp.200640—
+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
+6K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+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—
+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—
+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—