510(k) Report

Devices descending from K013946

340 later devices reach Flex 10 Accessory for the Afx Microwave Ablation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070023Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100Microsurgeon, Inc.200741—
+1K070311Cardioblate Gemini Surgical Ablation Device, Models 49260 and 49261Medtronic Vascular20071—
+1K061489Atrilaze MI Surgical Ablation SystemMedical Cv, Inc.20071—
+1K061865Flex 10 Mis Ablation Probe, Model FLX10MI-05Guidant Corp.20060—
+1K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…Intuitive Surgical, Inc.2004251—
+1K041739Edwards E360 Surgical Ablation DeviceEdwards Lifesciences, LLC20040—
+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—
+2K123329DA Vinvi Surgical SystemIntuitive Surgical, Inc.20143—
+2K100744Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc.201039—
+2K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000Intuitive Surgical, Inc.20091533
+2K090869Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula…Medtronic Perfusion Systems20090—
+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—
+2K072629Digimatch Robodoc Surgical SystemIntegrated Surgical Systems, Inc.200816—
+2K080292Epicor Ablation SystemSt Jude Medical200812
+2K043579Atricure Bipolar SystemAtriCure, Inc.200718—
+2K060346Ultrazonix Spine Minimal-Invasive Disc SystemUltrazonix Dnt AB20060—
+2K060054Oncobionic SystemOncobionics, Inc.200614—
+2K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005228—
+2K050369Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc.200523051
+2K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005229—
+2K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model…Intuitive Surgical, Inc.20052312
+3K250417Remanufactured EndoWrist Cobra Grasper (420190)Rebotix20250—
+3K250539Remanufactured EndoWrist Tenaculum Forceps (420207)Rebotix20250—
+3K250387Remanufactured EndoWrist Long Tip Forceps (420048)Rebotix20250—
+3K250399Remanufactured EndoWrist Cadiere Forceps (420049)Rebotix20250—
+3K241872Remanufactured EndoWrist ProGrasp Forceps (420093)Rebotix20240—
+3K240480IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation…Varian Medical Systems, Inc.20240—
+3K223080da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)Intuitive Surgical, Inc.202213—
+3K2104788mm Monopolar Curved ScissorsIconocare Health20220—
+3K211784da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.202114—
+3K202834da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.202015—
+3K183086da Vinci X and Xi Surgical SystemIntuitive Surgical, Inc.202016—
+3K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2019204
+3K182140da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201817—
+3K173585da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201818—
+3K173415EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc.20180—
+3K173842da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201818—
+3K1800338mm Monopolar Curved ScissorsIntuitive Surgical, Inc.201812
+3K172643da Vinci Xi Surgical System; da Vinci X Surgical SystemIntuitive Surgical, Inc.201818—
+3K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc.20170—
+3K171632da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201720—
+3K171699da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201714—
+3K170713da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201722—
+3K163118FLEX Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20170—
+3K161178da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201723—
+3K153276da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201623—
+3K160936Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc.20165—
+3K152578da Vinci Surgical System, Model IS4000Intuitive Surgical, Inc.201625—
+3K140585CTC Tcat (R)-Tplan (R) Surgical SystemCurexo Technology Corporation201410—
+3K140038Digimatch Orthodoc Robodoc Encore Surgical SystemCurexo Technology Corporation20140—
+3K131962DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.201422—
+3K131861DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc.201412480
+3K122532DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc.2013396
+3K130399Certus 140 Certusurggt Surgical ToolNeuwave Medical, Inc.20136—
+3K122217Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc.20128—
+3K123463Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc.20121482
+3K113237Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc.201238—
+3K112263Monopolar Curved Scissors Tip Cover AccessoryIntuitive Surgical, Inc.2011271
+3K110117Atricure Bipolar SystemAtriCure, Inc.20115—
+3K103428The Artas System From Restoration RoboticsRestoration Robotics, Inc.20113—
+3K101174Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2…AtriCure, Inc.20106—
+3K082497Intuitive Surgical Endowrist One Hot Shears InstrumentIntuitive Surgical, Inc.200923—
+3K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc.200921125
+3K081207Intuitive Surgical DA Vinci S Surgical System, Model IS2000, with DA Vinci Connect and…Intuitive Surgical, Inc.20087—
+3K082279Epicor Ablation Control System, Model Acs-US-2, Acs-Eur-2St Jude Medical20080—
+3K080287Oncobionic Bipolar ElectrodeAngioDynamics, Inc.20080—
+3K080202Oncobionic System with 6 Probe OutputOncobionics, Inc.2008111
+3K080509Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device…Medtronic, Inc.200810—
+3K080376Oncobionic SystemOncobionic Incorporated2008111
+3K080291Intuitive Surgical DA Vinci Endoscopic Instruments and Control System and Endowrist…Intuitive Surgical, Inc.200801
+3K070947Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments and Endowrist…Intuitive Surgical, Inc.200801
+3K072627Intuitive Surgical DA Vinci and DA Vinci S Surgical System and Endoscopic Instruments…Intuitive Surgical, Inc.20080—
+3K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc.20062244
+3K061260Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214Intuitive Surgical, Inc.20061541
+3K060391Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc.20061551
+4K252926Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical…Restore Robotics20260—
+4K240852da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)Intuitive Surgical, Inc.20250—
+4K233866Senhance Surgical SystemAsensus Surgical, Inc.20240—
+4K240723da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)Intuitive Surgical20241—
+4K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc.2024116
+4K231738NEUWAVE™ Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20230—
+4K231224da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.202313—
+4K223095Senhance Surgical SystemAsensus Surgical, Inc.20231Class I
+4K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear…AtriCure, Inc.20220—
+4K2200238mm Monopolar Curved ScissorsIntuitive Surgical, Inc.202211
+4K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc.20212—
+4K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc.20212—
+4K202571da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2020141
+4K192717da Vinci SP Surgical SystemIntuitive Surgical, Inc.202041
+4K192803da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical20200—
+4K190623Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation DeviceMedtronic20190—
+4K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device…Medtronic20182—
+4K173756Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc.20183—
+4K180351EndoWrist Mercury Bipolar GrasperIntuitive Surgical, Inc.201802
+4K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2018219
+4K171120Senhance Surgical Robotic SystemTransenterix, Inc.201712—
+4K170875da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments…Intuitive Surgical, Inc.20170—