510(k) Report

Devices descending from K811390

411 later devices reach CCS100 Cryosurgical System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111042Atricure Cryo ModuleAtriCure, Inc.201114—
+1K082074Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc.2009161
+1K060555Spraygenix Cryo Ablation SystemCrymed Technologies, Inc.200615—
+1K040809Crymed Cryo-AblatorCrymed Technologies, Inc.200416—
+1K974320Cryogen Cardiac Cryosurgical SystemCryogen, Inc.1998392—
+1K972662Cryogen Cryosurgical SystemCryogen, Inc.1997393—
+2K142203Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc.20149—
+2K142441cryoICE croablation probeAtriCure, Inc.20141—
+2K140058Atricure Cryo Module SystemAtriCure, Inc.2014102
+2K113021Trufreeze System, Trufreeze Spray KitCSA Medical, Inc.20120—
+2K112072Atricure Cryo Module SystemAtriCure, Inc.201113—
+2K101825Cryoballoon Ablation SystemC2 Therapeutics201011—
+2K072651Cryospray Ablation System, Model CC2-NamCSA Medical, Inc.20070—
+2K070893Cryospray Ablation System, Model CU 8407020500CSA Medical, Inc.200713—
+2K041340Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery2004268—
+2K013946Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc.2002340—
+2K011722Atricure Bipolar Coagulation SystemAtriCure, Inc.200192—
+3K243157AtriCure cryoICE BOX (ACM)AtriCure, Inc.20240—
+3K180138AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc.20184—
+3K180137AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation…AtriCure, Inc.20180—
+3K152337cryoFORM cryoICE cryoablation probeAtriCure, Inc.20162—
+3K133672Reprocessed Harmonic Ace Shears Without Adaptive Tissue TechnologyStryker Sustainability Solutions20140—
+3K131523Cryoballoon Focal Ablation SystemC2 Therapeutics2013102
+3K121507Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc.201211—
+3K082954Encage Bipolar RF ProbeTrod Medical SA20080—
+3K070023Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100Microsurgeon, Inc.200741—
+3K070311Cardioblate Gemini Surgical Ablation Device, Models 49260 and 49261Medtronic Vascular20071—
+3K061489Atrilaze MI Surgical Ablation SystemMedical Cv, Inc.20071—
+3K060054Oncobionic SystemOncobionics, Inc.200614—
+3K061544Stellartech 100 Coagulation SystemStellartech Research Corp.20060—
+3K061865Flex 10 Mis Ablation Probe, Model FLX10MI-05Guidant Corp.20060—
+3K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…Intuitive Surgical, Inc.2004251—
+3K041739Edwards E360 Surgical Ablation DeviceEdwards Lifesciences, LLC20040—
+3K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11…Epicor Medical, Inc.200422—
+3K022894Epicor Medical Ablation SystemEpicor Medical, Inc.200423—
+3K020919Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc.200290—
+4K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console…Medinice S.A.20260—
+4K200697AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation…AtriCure, Inc.20202—
+4K182565AtriCure cryoICE cryoSPHERE cryoablation probeAtriCure, Inc.20183—
+4K160994C2 CryoBalloon Focal Pear CatheterC2 Therapeutics, Inc.20160—
+4K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc.201661
+4K151054Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation SystemC2 Therapeutics, Inc.20158—
+4K123329DA Vinvi Surgical SystemIntuitive Surgical, Inc.20143—
+4K110117Atricure Bipolar SystemAtriCure, Inc.20115—
+4K100744Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc.201039—
+4K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000Intuitive Surgical, Inc.20091533
+4K090869Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula…Medtronic Perfusion Systems20090—
+4K082565Microsurgeon Microwave Tissue Ablation Device, Model Mtad-200Microsurgeon, Inc.20090—
+4K082409Solar Laser Ablation System, Models: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000…Endophotonix, Inc.20090—
+4K072629Digimatch Robodoc Surgical SystemIntegrated Surgical Systems, Inc.200816—
+4K080292Epicor Ablation SystemSt Jude Medical200812
+4K080287Oncobionic Bipolar ElectrodeAngioDynamics, Inc.20080—
+4K080202Oncobionic System with 6 Probe OutputOncobionics, Inc.2008111
+4K080376Oncobionic SystemOncobionic Incorporated2008111
+4K043579Atricure Bipolar SystemAtriCure, Inc.200718—
+4K063630Atricure Ablation SystemAtriCure, Inc.20077—
+4K060346Ultrazonix Spine Minimal-Invasive Disc SystemUltrazonix Dnt AB20060—
+4K053436Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical…Cryocath Technologies, Inc.2006221
+4K052893Atricure Transpolar SystemAtriCure, Inc.20058—
+4K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005228—
+4K050459Atricure Isolator Transpolar PenAtriCure, Inc.2005181
+4K050369Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc.200523051
+4K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005229—
+4K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model…Intuitive Surgical, Inc.20052312
+4K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc.200442—
+4K031247Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular200334—
+5K250417Remanufactured EndoWrist Cobra Grasper (420190)Rebotix20250—
+5K250539Remanufactured EndoWrist Tenaculum Forceps (420207)Rebotix20250—
+5K250387Remanufactured EndoWrist Long Tip Forceps (420048)Rebotix20250—
+5K250399Remanufactured EndoWrist Cadiere Forceps (420049)Rebotix20250—
+5K250371cryoICE cryoXT cryoablation probe (cryoXT)AtriCure, Inc.20250—
+5K241872Remanufactured EndoWrist ProGrasp Forceps (420093)Rebotix20240—
+5K240480IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation…Varian Medical Systems, Inc.20240—
+5K233170cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe…AtriCure, Inc.20230—
+5K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear…AtriCure, Inc.20220—
+5K223080da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)Intuitive Surgical, Inc.202213—
+5K2104788mm Monopolar Curved ScissorsIconocare Health20220—
+5K211784da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.202114—
+5K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc.20212—
+5K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc.20212—
+5K202834da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.202015—
+5K183086da Vinci X and Xi Surgical SystemIntuitive Surgical, Inc.202016—
+5K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2019204
+5K182140da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201817—
+5K173585da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201818—
+5K173415EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc.20180—
+5K173842da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201818—
+5K1800338mm Monopolar Curved ScissorsIntuitive Surgical, Inc.201812
+5K172643da Vinci Xi Surgical System; da Vinci X Surgical SystemIntuitive Surgical, Inc.201818—
+5K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc.201844
+5K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc.20170—
+5K171632da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201720—
+5K171699da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201714—
+5K170713da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201722—
+5K163118FLEX Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20170—
+5K161178da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201723—
+5K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc.201751
+5K153276da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201623—
+5K160936Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc.20165—
+5K152578da Vinci Surgical System, Model IS4000Intuitive Surgical, Inc.201625—