510(k) Report

Devices descending from K921884

1,365 later devices reach FORCE 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023765Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200242—
+1K013392Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation…Medtronic Vascular20021021
+1K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.19981,219—
+2K080509Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device…Medtronic, Inc.200810—
+2K073605Atricure Coolrail Linear PenAtriCure, Inc.200813—
+2K043579Atricure Bipolar SystemAtriCure, Inc.200718—
+2K070288Cardioblate Monopolar Pen, 60813, Cardioblate Monopolar XL, 60814Medtronic Vascular20072—
+2K063012Ncontact Coagulation System Kit, Model CSKNcontact Surgical, Inc.20066—
+2K061544Stellartech 100 Coagulation SystemStellartech Research Corp.20060—
+2K053436Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical…Cryocath Technologies, Inc.2006221
+2K050459Atricure Isolator Transpolar PenAtriCure, Inc.2005181
+2K050831Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp.200534—
+2K042909Stellartech Coagulation System, Models 1100C-115A & 1100C-230AStellartech Research Corp.200435—
+2K041383Stellartech Coagulation System, Models 1100C-115 and 1100C-230Stellartech Research Corp.200436—
+2K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc.200442—
+2K040240Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200437—
+2K022894Epicor Medical Ablation SystemEpicor Medical, Inc.200423—
+2K032721Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200338—
+2K032838Celon Ent SystemCelon AG Medical Instruments20033—
+2K032452Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230Stellartech Research Corp.200339—
+2K032062Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp.200341—
+2K031247Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular200334—
+2K022008Cardima Ablation SystemCardima, Inc.2003252
+2K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC200276—
+2K013873Cobra Cardiac Electrosurgical SystemBoston Scientific Corp200261—
+2K014290Entec Plasma WandsArthrocare Corp.2002119—
+2K012631Reprocessed Soft Tissue AblatorsAlliance Medical Corp.20011—
+2K992581Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands, Orthowands…Arthrocare Corp.199923—
+2K981870Visage Cosmetic Surgery SystemArthrocare Corp.19981,073—
+3K252043Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus…Olympus Winter & Ibe GmbH20250—
+3K191732Sutter RaVoR Bipolar ElectrodesSutter Medizintechnik GmbH20190—
+3K190623Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation DeviceMedtronic20190—
+3K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device…Medtronic20182—
+3K152703PlasmaBlade TnA Tonsil and Adenoid Dissection DeviceMedtronic Advanced Energy20160—
+3K160639Electrosurgical Generator ESG-200Olympus Winter & Ibe GmbH20160—
+3K150297PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy20150—
+3K123353Ciq Controller, Ciq WandsArthroCare Corporation20130—
+3K121878Cardioblate Cryoflex Surgical Ablation ProbesMedtronic, Inc.20122—
+3K122611Coolrail Linear Pen Model McriAtriCure, Inc.20123—
+3K121767Cardioblate Gemini Surgical Ablation DeviceMedtronic, Inc.201221
+3K110117Atricure Bipolar SystemAtriCure, Inc.20115—
+3K101174Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2…AtriCure, Inc.20106—
+3K091310Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682Dfine, Inc.201011—
+3K100543Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss201001
+3K100501Multifunctional Linear PenAtriCure, Inc.20109—
+3K093203Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831, 60832, 60841Medtronic, Inc.20103—
+3K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated201014—
+3K090721Cardioblate Maps Surgical Mapping, Ablation, Pacing and Sensing Device, Model 49205Medtronic20091—
+3K082074Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc.2009161
+3K082203Numeris Coagulation System with Visitrax, Model (S) CSK-021;CSK-022; CSK-023; CSK-025Ncontact Surgical, Inc.20084—
+3K082202HALO360 Energy Generator, Models 1100C-115B and 1100C-230BBarrx Medical, Incorporated20080—
+3K080292Epicor Ablation SystemSt Jude Medical200812
+3K070947Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments and Endowrist…Intuitive Surgical, Inc.200801
+3K072261Finesse SystemPrimaeva Medical, Inc.2007100—
+3K071819Ncontact Visitrax Guided Coagulation System Kit, Models CSK-212 and CSK-515Ncontact Surgical, Inc.20074—
+3K070374Arthrocare Ent Plasma WandArthrocare Corp.2007391
+3K062539Ncontact Coagulation System KitNcontact Surgical, Inc.20060—
+3K060054Oncobionic SystemOncobionics, Inc.200614—
+3K062441Barrx Halo Coagulation System; Generator, Model 90-9000; Output Cable, Model 90-9010…Barrx Medical, Incorporated20063—
+3K062225Halo Coagulation CatheterBarrx Medical, Incorporated200620—
+3K062140Surgifrost XL Cryosurgical Device, Model 60SFXL; Cryosurgical Console, Model 65CS1Cryocath Technologies, Inc.20061—
+3K061593Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1AtriCure, Inc.2006131
+3K060715Modification to: Cardima Ablation SystemCardima, Inc.200602
+3K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical20060—
+3K060169Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation…Barrx Medical, Incorporated200629—
+3K060400Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate BP2 Surgical Ablation…Medtronic, Inc.200614—
+3K053326Estech Cobra Electrosurgical Unit & CableEndoscopic Technologies, Inc.20067—
+3K041633Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc.20048—
+3K041285Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision…Gyrus Medical, Ltd.2004202
+3K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11…Epicor Medical, Inc.200422—
+3K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC200450—
+3K040219Cobra Surgical ProbeBoston Scientific Corp20040—
+3K033547Vnus Vessel and Tissue Coagulation SystemVnus Medical Technologies, Inc.20046—
+3K023288Cobra Bipolar Clamp, Model 15902Boston Scientific EP Technologies200346—
+3K021364Modification to Entec Plasma WandsArthrocare Corp.200294—
+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—
+4K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear…AtriCure, Inc.20220—
+4K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical…Medtronic, Inc.20220—
+4K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+4K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc.20212—
+4K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc.20212—
+4K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter…ArthroCare Corporation20202—
+4K200514Cardioblate Gemini-s Surgical Ablation DeviceMedtronic202011
+4K192027WEREWOLF COBLATION System, COBLATION HALO WandArthroCare Corporation20193—
+4K192125Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenAtriCure, Inc.20191—
+4K191601Valleylab FT10 Electrosurgical PlatformCovidien201911
+4K183595Aqua Medical RF Vapor SystemAqua Medical, Inc.20194—
+4K183065Coolrail Linear PenAtriCure, Inc.20182—
+4K172647Reprocessed ArthroCare ENT CoblatorRenovo, Inc.20180—
+4K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+4K142480OsteoCool V-2 RF Ablation SystemBaylis Medical Company, Inc.20159—
+4K142289PK SpatulaGyrus Acmi, Inc.20141—
+4K142203Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc.20149—
+4K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated…ArthroCare Corporation201443
+4K142441cryoICE croablation probeAtriCure, Inc.20141—
+4K141357Barrx Flex Rfa Energy GeneratorCovidien Iic20141—
+4K130689Symphony RF GeneratorThermigen, Inc.201311—