510(k) Report

Devices descending from K953637

424 later devices reach CMS Accuprobe 550/530 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K972662Cryogen Cryosurgical SystemCryogen, Inc.1997393—
+1K964336CMS Accuprobe 610, 620, 630, 640, 650, 660, 670, 680Cryomedical Sciences, Inc.199729—
+2K072883Ice-SenseArbel Medical, Ltd.200726—
+2K062175Cryocare CN2 SystemEndocare, Inc.20060—
+2K982055Accuprobe 800 Series Model Numbers : 810, 820, 830, 840, 850, 860, 870 and 880Cryomedical Sciences, Inc.19981—
+2K974320Cryogen Cardiac Cryosurgical SystemCryogen, Inc.1998392—
+3K102360Icesence 3IceCure Medical, Ltd.2010251
+3K041340Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery2004268—
+3K013946Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc.2002340—
+3K011722Atricure Bipolar Coagulation SystemAtriCure, Inc.200192—
+4K183213IceSense 3, ProSense, MultiSenseIceCure Medical, Ltd.20193—
+4K133258Trufreeze SystemCSA Medical, Inc.2014201
+4K082954Encage Bipolar RF ProbeTrod Medical SA20080—
+4K070023Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100Microsurgeon, Inc.200741—
+4K070311Cardioblate Gemini Surgical Ablation Device, Models 49260 and 49261Medtronic Vascular20071—
+4K061489Atrilaze MI Surgical Ablation SystemMedical Cv, Inc.20071—
+4K060054Oncobionic SystemOncobionics, Inc.200614—
+4K061544Stellartech 100 Coagulation SystemStellartech Research Corp.20060—
+4K061865Flex 10 Mis Ablation Probe, Model FLX10MI-05Guidant Corp.20060—
+4K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…Intuitive Surgical, Inc.2004251—
+4K041739Edwards E360 Surgical Ablation DeviceEdwards Lifesciences, LLC20040—
+4K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11…Epicor Medical, Inc.200422—
+4K022894Epicor Medical Ablation SystemEpicor Medical, Inc.200423—
+4K020919Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc.200290—
+5K240892XSense Cryoablation System with CryoprobesIceCure Medical, Ltd.20242—
+5K143625truFreeze SystemCSA Medical, Inc.2015191
+5K123329DA Vinvi Surgical SystemIntuitive Surgical, Inc.20143—
+5K110117Atricure Bipolar SystemAtriCure, Inc.20115—
+5K100744Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc.201039—
+5K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000Intuitive Surgical, Inc.20091533
+5K090869Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula…Medtronic Perfusion Systems20090—
+5K082565Microsurgeon Microwave Tissue Ablation Device, Model Mtad-200Microsurgeon, Inc.20090—
+5K082409Solar Laser Ablation System, Models: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000…Endophotonix, Inc.20090—
+5K072629Digimatch Robodoc Surgical SystemIntegrated Surgical Systems, Inc.200816—
+5K080292Epicor Ablation SystemSt Jude Medical200812
+5K080287Oncobionic Bipolar ElectrodeAngioDynamics, Inc.20080—
+5K080202Oncobionic System with 6 Probe OutputOncobionics, Inc.2008111
+5K080376Oncobionic SystemOncobionic Incorporated2008111
+5K043579Atricure Bipolar SystemAtriCure, Inc.200718—
+5K063630Atricure Ablation SystemAtriCure, Inc.20077—
+5K060346Ultrazonix Spine Minimal-Invasive Disc SystemUltrazonix Dnt AB20060—
+5K053436Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical…Cryocath Technologies, Inc.2006221
+5K052893Atricure Transpolar SystemAtriCure, Inc.20058—
+5K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005228—
+5K050459Atricure Isolator Transpolar PenAtriCure, Inc.2005181
+5K050369Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc.200523051
+5K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005229—
+5K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model…Intuitive Surgical, Inc.20052312
+5K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc.200442—
+5K031247Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular200334—
+6K260377XSense Cryoablation System with CryoProbesIceCure Medical, Ltd.20260—
+6K250417Remanufactured EndoWrist Cobra Grasper (420190)Rebotix20250—
+6K250539Remanufactured EndoWrist Tenaculum Forceps (420207)Rebotix20250—
+6K250387Remanufactured EndoWrist Long Tip Forceps (420048)Rebotix20250—
+6K250399Remanufactured EndoWrist Cadiere Forceps (420049)Rebotix20250—
+6K243042Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd.20250—
+6K241872Remanufactured EndoWrist ProGrasp Forceps (420093)Rebotix20240—
+6K240480IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation…Varian Medical Systems, Inc.20240—
+6K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear…AtriCure, Inc.20220—
+6K223080da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)Intuitive Surgical, Inc.202213—
+6K2104788mm Monopolar Curved ScissorsIconocare Health20220—
+6K211784da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.202114—
+6K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc.20212—
+6K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc.20212—
+6K202834da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.202015—
+6K183086da Vinci X and Xi Surgical SystemIntuitive Surgical, Inc.202016—
+6K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2019204
+6K182140da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201817—
+6K173585da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201818—
+6K173415EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc.20180—
+6K173842da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201818—
+6K1800338mm Monopolar Curved ScissorsIntuitive Surgical, Inc.201812
+6K172643da Vinci Xi Surgical System; da Vinci X Surgical SystemIntuitive Surgical, Inc.201818—
+6K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc.20170—
+6K171632da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201720—
+6K171699da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201714—
+6K170713da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201722—
+6K163118FLEX Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20170—
+6K161178da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201723—
+6K153276da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201623—
+6K160936Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc.20165—
+6K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc.201661
+6K152578da Vinci Surgical System, Model IS4000Intuitive Surgical, Inc.201625—
+6K152668truFreeze SystemCSA Medical, Inc.201510—
+6K150920truFreeze SystemCSA Medical, Inc.201511—
+6K140585CTC Tcat (R)-Tplan (R) Surgical SystemCurexo Technology Corporation201410—
+6K140038Digimatch Orthodoc Robodoc Encore Surgical SystemCurexo Technology Corporation20140—
+6K131962DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.201422—
+6K131861DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc.201412480
+6K122532DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc.2013396
+6K130399Certus 140 Certusurggt Surgical ToolNeuwave Medical, Inc.20136—
+6K122217Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc.20128—
+6K123463Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc.20121482
+6K121878Cardioblate Cryoflex Surgical Ablation ProbesMedtronic, Inc.20122—
+6K113237Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc.201238—
+6K102329Nanoknife SystemAngioDynamics, Inc.2011101
+6K112263Monopolar Curved Scissors Tip Cover AccessoryIntuitive Surgical, Inc.2011271
+6K103428The Artas System From Restoration RoboticsRestoration Robotics, Inc.20113—
+6K101174Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2…AtriCure, Inc.20106—
+6K100501Multifunctional Linear PenAtriCure, Inc.20109—