510(k) Report

Devices descending from K003978

413 later devices reach Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073605Atricure Coolrail Linear PenAtriCure, Inc.200813—
+1K072870Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc.200811—
+1K070023Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100Microsurgeon, Inc.200741—
+1K043579Atricure Bipolar SystemAtriCure, Inc.200718—
+1K061489Atrilaze MI Surgical Ablation SystemMedical Cv, Inc.20071—
+1K042096Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating SystemMisonix, Inc.20062—
+1K041340Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery2004268—
+1K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11…Epicor Medical, Inc.200422—
+1K022894Epicor Medical Ablation SystemEpicor Medical, Inc.200423—
+1K013873Cobra Cardiac Electrosurgical SystemBoston Scientific Corp200261—
+1K013946Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc.2002340—
+1K013392Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation…Medtronic Vascular20021021
+2K181941Swift SystemEmblation, Ltd.20183—
+2K122611Coolrail Linear Pen Model McriAtriCure, Inc.20123—
+2K110117Atricure Bipolar SystemAtriCure, Inc.20115—
+2K101174Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2…AtriCure, Inc.20106—
+2K100744Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc.201039—
+2K100501Multifunctional Linear PenAtriCure, Inc.20109—
+2K082819Dermatologic Treatment System (DTS) G2Miramar Labs, Inc.200910—
+2K082565Microsurgeon Microwave Tissue Ablation Device, Model Mtad-200Microsurgeon, Inc.20090—
+2K082409Solar Laser Ablation System, Models: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000…Endophotonix, Inc.20090—
+2K080292Epicor Ablation SystemSt Jude Medical200812
+2K070779Sonatherm 600I Ultrasonic Lesion Generating SystemMisonix, Inc.20081—
+2K080509Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device…Medtronic, Inc.200810—
+2K070288Cardioblate Monopolar Pen, 60813, Cardioblate Monopolar XL, 60814Medtronic Vascular20072—
+2K070311Cardioblate Gemini Surgical Ablation Device, Models 49260 and 49261Medtronic Vascular20071—
+2K060346Ultrazonix Spine Minimal-Invasive Disc SystemUltrazonix Dnt AB20060—
+2K063012Ncontact Coagulation System Kit, Model CSKNcontact Surgical, Inc.20066—
+2K060054Oncobionic SystemOncobionics, Inc.200614—
+2K061865Flex 10 Mis Ablation Probe, Model FLX10MI-05Guidant Corp.20060—
+2K053436Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical…Cryocath Technologies, Inc.2006221
+2K053326Estech Cobra Electrosurgical Unit & CableEndoscopic Technologies, Inc.20067—
+2K050459Atricure Isolator Transpolar PenAtriCure, Inc.2005181
+2K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…Intuitive Surgical, Inc.2004251—
+2K041739Edwards E360 Surgical Ablation DeviceEdwards Lifesciences, LLC20040—
+2K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc.200442—
+2K040219Cobra Surgical ProbeBoston Scientific Corp20040—
+2K031247Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular200334—
+2K023288Cobra Bipolar Clamp, Model 15902Boston Scientific EP Technologies200346—
+2K022008Cardima Ablation SystemCardima, Inc.2003252
+3K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation Limited20250—
+3K240480IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation…Varian Medical Systems, Inc.20240—
+3K222388swiftPro SystemEmblation, Ltd.20232—
+3K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear…AtriCure, Inc.20220—
+3K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc.20212—
+3K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc.20212—
+3K190623Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation DeviceMedtronic20190—
+3K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device…Medtronic20182—
+3K183065Coolrail Linear PenAtriCure, Inc.20182—
+3K163118FLEX Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20170—
+3K160936Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc.20165—
+3K150019TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc.20160—
+3K123329DA Vinvi Surgical SystemIntuitive Surgical, Inc.20143—
+3K130399Certus 140 Certusurggt Surgical ToolNeuwave Medical, Inc.20136—
+3K130521Isolator Linear PenAtriCure, Inc.20133—
+3K122217Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc.20128—
+3K121878Cardioblate Cryoflex Surgical Ablation ProbesMedtronic, Inc.20122—
+3K121767Cardioblate Gemini Surgical Ablation DeviceMedtronic, Inc.201221
+3K113475Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech201245
+3K113237Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc.201238—
+3K103014Miradry SystemMiramar Labs, Inc.201152
+3K093203Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831, 60832, 60841Medtronic, Inc.20103—
+3K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000Intuitive Surgical, Inc.20091533
+3K090869Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula…Medtronic Perfusion Systems20090—
+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—
+3K082279Epicor Ablation Control System, Model Acs-US-2, Acs-Eur-2St Jude Medical20080—
+3K072629Digimatch Robodoc Surgical SystemIntegrated Surgical Systems, Inc.200816—
+3K080287Oncobionic Bipolar ElectrodeAngioDynamics, Inc.20080—
+3K080202Oncobionic System with 6 Probe OutputOncobionics, Inc.2008111
+3K080376Oncobionic SystemOncobionic Incorporated2008111
+3K070947Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments and Endowrist…Intuitive Surgical, Inc.200801
+3K071819Ncontact Visitrax Guided Coagulation System Kit, Models CSK-212 and CSK-515Ncontact Surgical, Inc.20074—
+3K062539Ncontact Coagulation System KitNcontact Surgical, Inc.20060—
+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
+3K060400Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate BP2 Surgical Ablation…Medtronic, Inc.200614—
+3K053100Estech Cobra Bipolar SystemEndoscopic Technologies, Inc.20052—
+3K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005228—
+3K050369Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc.200523051
+3K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005229—
+3K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model…Intuitive Surgical, Inc.20052312
+4K250417Remanufactured EndoWrist Cobra Grasper (420190)Rebotix20250—
+4K250539Remanufactured EndoWrist Tenaculum Forceps (420207)Rebotix20250—
+4K250387Remanufactured EndoWrist Long Tip Forceps (420048)Rebotix20250—
+4K250399Remanufactured EndoWrist Cadiere Forceps (420049)Rebotix20250—
+4K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc.20250—
+4K241872Remanufactured EndoWrist ProGrasp Forceps (420093)Rebotix20240—
+4K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc.20240—
+4K240518swiftPro™ SystemEmblation Limited20241—
+4K231738NEUWAVE™ Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20230—
+4K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical…Medtronic, Inc.20220—
+4K223080da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)Intuitive Surgical, Inc.202213—
+4K2104788mm Monopolar Curved ScissorsIconocare Health20220—
+4K211784da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.202114—
+4K202834da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.202015—
+4K200514Cardioblate Gemini-s Surgical Ablation DeviceMedtronic202011
+4K183086da Vinci X and Xi Surgical SystemIntuitive Surgical, Inc.202016—