510(k) Report

Devices descending from K962321

1,327 later devices reach Arthocare Arthroscopic Electrosurgery System Model 970 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012640Electrosurgical Cutting and Coagulation Accessories, Electrosurgical WandsMedical Instruments Technology, Inc.200201
+1K992805Oratec Ablator-S Probes (Monopolar Ablation Suction Probes)Oratec Interventions, Inc.20000—
+1K963123Arthrocare Arthroscopic Eletrosurgery System (Model 980)Arthrocare Corp.19961,324—
+2K012631Reprocessed Soft Tissue AblatorsAlliance Medical Corp.20011—
+2K992581Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands, Orthowands…Arthrocare Corp.199923—
+2K993009Hydrocision Arthrojet System with CauteryHydrocision, Inc.19991—
+2K981870Visage Cosmetic Surgery SystemArthrocare Corp.19981,073—
+2K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.19981,219—
+2K971532Arthrocare Electrosurgery SystemArthrocare Corp.19971,029—
+3K091310Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682Dfine, Inc.201011—
+3K072261Finesse SystemPrimaeva Medical, Inc.2007100—
+3K062539Ncontact Coagulation System KitNcontact Surgical, Inc.20060—
+3K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical20060—
+3K033547Vnus Vessel and Tissue Coagulation SystemVnus Medical Technologies, Inc.20046—
+3K032838Celon Ent SystemCelon AG Medical Instruments20033—
+3K031406Exojet Tissue Management SystemMitek Worldwide20030—
+3K023765Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200242—
+3K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC200276—
+3K014290Entec Plasma WandsArthrocare Corp.2002119—
+3K011190Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System)Surx, Inc.20023—
+3K013139Stellartech Coagulation SystemStellartech Research Corp.200142—
+3K012679Reprocessed RF Arthroscopy ProbesSterilmed, Inc.200101
+3K012129Ortho Development Orion-I Emf SystemOrtho Development Corp.20010—
+3K000944Thermage Thermacool SystemThermage, Inc.20001,069—
+3K992180Visage Cosmetic Surgery, Model V5000Arthrocare Corp.20003—
+3K992972Arthrocare System 2000 Controller, Arthrocare Cable, Footswitch, Powercord, Arthrocare…Arthrocare Corp.19993—
+3K974521Vnus Closure SystemVnus Medical Technologies, Inc.1998977—
+4K252043Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus…Olympus Winter & Ibe GmbH20250—
+4K191732Sutter RaVoR Bipolar ElectrodesSutter Medizintechnik GmbH20190—
+4K152703PlasmaBlade TnA Tonsil and Adenoid Dissection DeviceMedtronic Advanced Energy20160—
+4K160639Electrosurgical Generator ESG-200Olympus Winter & Ibe GmbH20160—
+4K142480OsteoCool V-2 RF Ablation SystemBaylis Medical Company, Inc.20159—
+4K150297PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy20150—
+4K130689Symphony RF GeneratorThermigen, Inc.201311—
+4K123353Ciq Controller, Ciq WandsArthroCare Corporation20130—
+4K111523Osteocool (TM) RF Ablation SystemBaylis Medical Co., Inc.20120—
+4K100543Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss201001
+4K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated201014—
+4K082391Primaeva Medical Renesis SystemPrimaeva Medical, Inc.200959—
+4K082962Tivamed Cooled RF System, Model 78001Tivamed, Inc.20087—
+4K080145Primaeva Medical SystemPrimaeva Medical, Inc.200899—
+4K072126Habib VesealEmcision, Ltd.20070—
+4K070374Arthrocare Ent Plasma WandArthrocare Corp.2007391
+4K061544Stellartech 100 Coagulation SystemStellartech Research Corp.20060—
+4K052003Vnus RFS, Model RFS-6-XX (XX = 10, 12, 13, & 15); Vnus RFS Flex, Model RFX-6-XX (XX =…Vnus Medical Technologies, Inc.20055—
+4K050831Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp.200534—
+4K043402Thermage Thermacool SystemThermage, Inc.2005124—
+4K042909Stellartech Coagulation System, Models 1100C-115A & 1100C-230AStellartech Research Corp.200435—
+4K041633Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc.20048—
+4K041285Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision…Gyrus Medical, Ltd.2004202
+4K041383Stellartech Coagulation System, Models 1100C-115 and 1100C-230Stellartech Research Corp.200436—
+4K040240Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200437—
+4K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC200450—
+4K033942Thermage Thermacool SystemThermage, Inc.2004527—
+4K032721Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200338—
+4K032452Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230Stellartech Research Corp.200339—
+4K032062Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp.200341—
+4K023111Gyrus Plasma Skin Resurfacing SystemGyrus Medical, Inc.20030—
+4K023624SLT Venous Fiber Delivery Systems, Model…Surgical Laser Technologies, Inc.20032—
+4K021402Thermage Thermacool TC SystemThermage, Inc.2002789—
+4K022266Aurora SRSyneron Medical, Ltd.2002705—
+4K021149Aurora DSSyneron Medical, Ltd.2002750—
+4K020952Surx RF SystemSurx, Inc.20021—
+4K021364Modification to Entec Plasma WandsArthrocare Corp.200294—
+4K014251Ntero Hotrod SystemNtero Surgical, Inc.20020—
+4K020126Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories…Surx, Inc.20022—
+4K013639Thermage Thermacool TC SystemThermage, Inc.2002799—
+4K012398Diomed 15 Diode LaserDiomed, Ltd.2002714—
+4K013034Modification to: Thermacool IiaThermage, Inc.2001800—
+4K982816Vnus Closure SystemVnus Medical Technologies, Inc.1999973—
+5K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+5K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF…Venclose, Inc.202121
+5K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter…ArthroCare Corporation20202—
+5K192027WEREWOLF COBLATION System, COBLATION HALO WandArthroCare Corporation20193—
+5K183595Aqua Medical RF Vapor SystemAqua Medical, Inc.20194—
+5K181044400um Perforator and Accessory Vein Ablation KitAngioDynamics, Inc.20180—
+5K173214NES Reprocessed RF Stylet (RFS)Northeast Scientific, Inc. (Nes)20180—
+5K172647Reprocessed ArthroCare ENT CoblatorRenovo, Inc.20180—
+5K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+5K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+5K162547Viveve SystemViveve, Inc.20166—
+5K161043Profound SystemSyneron Candela Corporation20160—
+5K161661Thermi RF AccessoriesThermi20163—
+5K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+5K151793InMode RF SystemInmode MD, Ltd.20161—
+5K152057OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc.20158—
+5K142289PK SpatulaGyrus Acmi, Inc.20141—
+5K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated…ArthroCare Corporation201443
+5K141357Barrx Flex Rfa Energy GeneratorCovidien Iic20141—
+5K130501IntensifEndymed Medical, Ltd.201457—
+5K130623Barrx Channel Rfa Endoscopic CatheterCovidien, LLC20131—
+5K122652Arthrocare Turbinator WandArthroCare Corporation20133—
+5K121481Infini Radiofrequency SystemLutronic Corporation201357—
+5K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+5K121678DTADGyrus Acmi, Inc.20122—
+5K112454HALO60 Ablation CatheterBarrx Medical, Inc.20124—
+5K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+5K101111Halo Ablation Catheter Model 90-9100, HALO90 Ultra Ablation Catheter Model 90-9200Barrx Medical, Inc.201011
+5K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+5K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—