510(k) Report

Devices descending from K973478

1,219 later devices reach Arthrocare Sinus Electrosurgery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032838Celon Ent SystemCelon AG Medical Instruments20033—
+1K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC200276—
+1K014290Entec Plasma WandsArthrocare Corp.2002119—
+1K012631Reprocessed Soft Tissue AblatorsAlliance Medical Corp.20011—
+1K992581Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands, Orthowands…Arthrocare Corp.199923—
+1K981870Visage Cosmetic Surgery SystemArthrocare Corp.19981,073—
+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—
+2K091310Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682Dfine, Inc.201011—
+2K100543Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss201001
+2K072261Finesse SystemPrimaeva Medical, Inc.2007100—
+2K070374Arthrocare Ent Plasma WandArthrocare Corp.2007391
+2K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical20060—
+2K041633Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc.20048—
+2K041285Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision…Gyrus Medical, Ltd.2004202
+2K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC200450—
+2K033547Vnus Vessel and Tissue Coagulation SystemVnus Medical Technologies, Inc.20046—
+2K021364Modification to Entec Plasma WandsArthrocare Corp.200294—
+2K012679Reprocessed RF Arthroscopy ProbesSterilmed, Inc.200101
+2K012129Ortho Development Orion-I Emf SystemOrtho Development Corp.20010—
+2K000944Thermage Thermacool SystemThermage, Inc.20001,069—
+2K992180Visage Cosmetic Surgery, Model V5000Arthrocare Corp.20003—
+3K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+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—
+3K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+3K142480OsteoCool V-2 RF Ablation SystemBaylis Medical Company, Inc.20159—
+3K142289PK SpatulaGyrus Acmi, Inc.20141—
+3K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated…ArthroCare Corporation201443
+3K130689Symphony RF GeneratorThermigen, Inc.201311—
+3K122652Arthrocare Turbinator WandArthroCare Corporation20133—
+3K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+3K121678DTADGyrus Acmi, Inc.20122—
+3K111523Osteocool (TM) RF Ablation SystemBaylis Medical Co., Inc.20120—
+3K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+3K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+3K082391Primaeva Medical Renesis SystemPrimaeva Medical, Inc.200959—
+3K080844G3 Generator and Accessories-Dissector Plasma KnifeGyrus Acmi, Inc.20091—
+3K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.20098—
+3K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080—
+3K082962Tivamed Cooled RF System, Model 78001Tivamed, Inc.20087—
+3K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc.20081—
+3K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+3K080145Primaeva Medical SystemPrimaeva Medical, Inc.200899—
+3K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.200514—
+3K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc.20056—
+3K052003Vnus RFS, Model RFS-6-XX (XX = 10, 12, 13, & 15); Vnus RFS Flex, Model RFX-6-XX (XX =…Vnus Medical Technologies, Inc.20055—
+3K043402Thermage Thermacool SystemThermage, Inc.2005124—
+3K033942Thermage Thermacool SystemThermage, Inc.2004527—
+3K030033Lumenis Family of Disposable Contact Tip Delivery DevicesLumenis, Ltd.20030—
+3K023111Gyrus Plasma Skin Resurfacing SystemGyrus Medical, Inc.20030—
+3K030108Arthrocare Ent Coblator Surgery SystemArthrocare Corp.2003921
+3K021402Thermage Thermacool TC SystemThermage, Inc.2002789—
+3K022266Aurora SRSyneron Medical, Ltd.2002705—
+3K021149Aurora DSSyneron Medical, Ltd.2002750—
+3K013639Thermage Thermacool TC SystemThermage, Inc.2002799—
+3K013034Modification to: Thermacool IiaThermage, Inc.2001800—
+4K253680LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation20260—
+4K251996ENTire IRE SystemEntire Medical, Ltd.20261—
+4K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System…ArthroCare Corporation20230—
+4K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc.20220—
+4K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF…Venclose, Inc.202121
+4K181044400um Perforator and Accessory Vein Ablation KitAngioDynamics, Inc.20180—
+4K173214NES Reprocessed RF Stylet (RFS)Northeast Scientific, Inc. (Nes)20180—
+4K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+4K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+4K161038PK MorcellatorGyrus Acmi, Inc.20160—
+4K162547Viveve SystemViveve, Inc.20166—
+4K161043Profound SystemSyneron Candela Corporation20160—
+4K161661Thermi RF AccessoriesThermi20163—
+4K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+4K151793InMode RF SystemInmode MD, Ltd.20161—
+4K152702Ent Biotech Solutions Tissue Removal Device (Elasso)Ent Biotech Solutions20160—
+4K152057OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc.20158—
+4K142350PK J-HookGyrus Acmi, Inc.201511
+4K142525PK Lap LoopOlympus Winter & Ibe GmbH20140—
+4K130501IntensifEndymed Medical, Ltd.201457—
+4K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+4K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+4K131205Arthrocare Head and Neck Coblation WandArthroCare Corporation20130—
+4K130305Lina Bipolar Loop; Standard Size, Large Size, Extra Large SizeLina Medical Aps20130—
+4K121481Infini Radiofrequency SystemLutronic Corporation201357—
+4K122605PKS BillGyrus Acmi, Inc.20121—
+4K103775Peak Suction CoagulatorPeak Surgical, Inc.20111—
+4K102366Finess EndoscopeEntellus Medical, Inc.20110—
+4K102709Peak Plasmablade Plus Tissue Dissection DevicePeak Surgical, Inc.20100—
+4K100896Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc.201031
+4K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+4K091674Arthrocare Coblator IQ SystemArthrocare Corp.20101—
+4K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+4K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+4K083352Veinwave, TC3000Newlands Clinical Trials, Ltd.20094—
+4K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+4K082956Alpha Orthopaedics AT2 SystemAlpha Orthopaedics20081—
+4K081766PKS Omni InstrumentGyrus-Acmi L.P.200831