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
+1K150637Aerin Medical Wand Model FG011Aerin Medical, Inc.201511—
+1K032838Celon Ent SystemCelon AG Medical Instruments20033—
+1K014290Entec Plasma WandsArthrocare Corp.2002119—
+1K011634Arthrocare Controller, Model H2000; Arthrocare Cable, Model H0970-02; Footswitch, Model…Arthrocare Corp.200141—
+2K252043Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus…Olympus Winter & Ibe GmbH20250—
+2K191732Sutter RaVoR Bipolar ElectrodesSutter Medizintechnik GmbH20190—
+2K161994Aerin Medical StylusAerin Medical, Inc.201610—
+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
+2K041810Serfas Energy SystemStryker Endoscopy2004173
+2K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC200276—
+2K021364Modification to Entec Plasma WandsArthrocare Corp.200294—
+2K020832Arthrocare Controller, Arthrocare Cable, Foot Control, Power Cord, WandsArthrocare Corp.200240—
+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—
+3K172608Medline ReNewal Reprocessed Stryker SERF AS Energy ProbesSurgical Instrument Service and Savings, Inc.20170—
+3K162810InSeca ARC Stylus, Aerin ConsoleAerin Medical, Inc.20179—
+3K160050SERFAS 90-S Electrosurgical ProbeStryker Corporation20161—
+3K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated…ArthroCare Corporation201443
+3K122652Arthrocare Turbinator WandArthroCare Corporation20133—
+3K121855Resprocessed Serfas Energy ProbeStryker Sustainability Solutions20120—
+3K113545Vapr Vue Generator, Vapr 3 Electrosurgical System, Vapr II Electrosurgical System…Depuy Mitek, A Johnson & Johnson Company20127—
+3K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+3K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.20098—
+3K071859Stryker Crossfire SystemStryker Endoscopy200742
+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—
+3K040338Arthrocare Controller, Cable, Foot Control, Power Cord, Wands, Models H0970-02…Arthrocare Corp.200424—
+3K030033Lumenis Family of Disposable Contact Tip Delivery DevicesLumenis, Ltd.20030—
+3K031029Arthrocare Bipolar Electrosurgery SystemArthrocare Corp.20030—
+3K030108Arthrocare Ent Coblator Surgery SystemArthrocare Corp.2003921
+4K260255AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)Aventix Medical, Inc.20260—
+4K253680LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation20260—
+4K251996ENTire IRE SystemEntire Medical, Ltd.20261—
+4K252666Articulator Arthroscopic BurJoint Preservation Innovations, LLC20250—
+4K242630Aerin ConsoleAerin Medical, Inc.20240—
+4K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System…ArthroCare Corporation20230—
+4K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+4K192471RHIN1 StylusAerin Medical, Inc.20194—
+4K173740Reprocessed DePuy Mitek Ablation WandRenovo, Inc.20180—
+4K171391Stryker 90-S Max SERFAS Energy ProbeStryker20180—
+4K172529Vivaer ARC StylusAerin Medical, Inc.20171—
+4K162770Relign SystemRelign Corporation20172—
+4K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+4K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+4K152702Ent Biotech Solutions Tissue Removal Device (Elasso)Ent Biotech Solutions20160—
+4K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation201632
+4K143475VAPR Tripolar Suction ElectrodeDepuy Mitek201501
+4K142289PK SpatulaGyrus Acmi, Inc.20141—
+4K140896Vapr Arctic Suction ElectrodeDepuy Mitek, A Johnson & Johnson Company20140—
+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—
+4K071963Modification to: Arthrocare ArthrowandsArthrocare Corp.200721—
+4K070351Space 360 Delivery SystemDfine, Inc.20071—
+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—
+5K241008Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece…Relign Corporation, Subsidiary of Zimmer Biomet20240—
+5K233493Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece…Relign Corporation20231—
+5K231126Eblator DeviceE Surgical, LLC20231—
+5K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc.20220—
+5K212666Neuromark SystemNeurent Medical20213—
+5K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+5K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+5K200300VivAer StylusAerin Medical, Inc.202001
+5K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+5K173741Reprocessed ArthoCare Ablation WandRenovo, Inc.20180—
+5K170908PK AIMGyrus Acmi, Inc.20170—
+5K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions201701
+5K161038PK MorcellatorGyrus Acmi, Inc.20160—
+5K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm…Bovie Medical Corporation201623
+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
+5K090986Stabili Erx Bone Cement, Model 1135,Stabilit Vertebral Augmentation System (for Use W/…Dfine, Inc.20090—
+5K081766PKS Omni InstrumentGyrus-Acmi L.P.200831