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
+4K192125Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenAtriCure, Inc.20191—
+4K190587Coolrail Linear PenAtriCure, Inc.20191—
+4K191601Valleylab FT10 Electrosurgical PlatformCovidien201911
+4K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2019204
+4K190151COBRA Fusion Ablation SystemAtriCure, Inc.20190—
+4K182140da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201817—
+4K173756Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc.20183—
+4K173585da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201818—
+4K173415EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc.20180—
+4K173842da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201818—
+4K1800338mm Monopolar Curved ScissorsIntuitive Surgical, Inc.201812
+4K172643da Vinci Xi Surgical System; da Vinci X Surgical SystemIntuitive Surgical, Inc.201818—
+4K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc.20170—
+4K171632da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201720—
+4K171699da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201714—
+4K170713da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201722—
+4K161178da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201723—
+4K163408Isolator Multifunctional Linear PenAtriCure, Inc.20172—
+4K153276da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201623—
+4K152578da Vinci Surgical System, Model IS4000Intuitive Surgical, Inc.201625—
+4K143203AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe…Medwaves Incorporated20150—
+4K141511SIDELAZE800 Laser Beam Delivery Accessory for Cynosure 1440MM Wavelength LasersCynosure, Inc.20150—
+4K142203Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc.20149—
+4K142441cryoICE croablation probeAtriCure, Inc.20141—
+4K140585CTC Tcat (R)-Tplan (R) Surgical SystemCurexo Technology Corporation201410—
+4K140038Digimatch Orthodoc Robodoc Encore Surgical SystemCurexo Technology Corporation20140—
+4K133821Emprint Ablation SystemCovidien, LLC2014297
+4K131962DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.201422—
+4K131861DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc.201412480
+4K131162Miradry SystemMiramar Labs, Inc.201331
+4K122532DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc.2013396
+4K123733Cardioblate Cryoflex Surgical Ablation SystemMedtronic, Inc.201315
+4K123463Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc.20121482
+4K120857Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.20122—
+4K121451Cardioblate Maps Surgical Mapping, Ablation, Pacing , and Sensing DeviceMedtronic, Inc.20120—
+4K102329Nanoknife SystemAngioDynamics, Inc.2011101
+4K112263Monopolar Curved Scissors Tip Cover AccessoryIntuitive Surgical, Inc.2011271
+4K111042Atricure Cryo ModuleAtriCure, Inc.201114—
+4K103428The Artas System From Restoration RoboticsRestoration Robotics, Inc.20113—
+4K100224Estech Cobra Bipolsr IIEndoscopic Technologies, Inc. D/B/A Estech20101—
+4K082497Intuitive Surgical Endowrist One Hot Shears InstrumentIntuitive Surgical, Inc.200923—
+4K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc.200921125
+4K090202Numeris Guided Coagulation System with Visitrax, Models CSK-121, -122, -123 and -125Ncontact Surgical, Inc.20093—
+4K081207Intuitive Surgical DA Vinci S Surgical System, Model IS2000, with DA Vinci Connect and…Intuitive Surgical, Inc.20087—
+4K081082U-Clip Uni-Fire, Model M65Medtronic, Inc.20080—
+4K080291Intuitive Surgical DA Vinci Endoscopic Instruments and Control System and Endowrist…Intuitive Surgical, Inc.200801
+4K072627Intuitive Surgical DA Vinci and DA Vinci S Surgical System and Endoscopic Instruments…Intuitive Surgical, Inc.20080—
+4K063630Atricure Ablation SystemAtriCure, Inc.20077—
+4K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc.20062244
+4K061544Stellartech 100 Coagulation SystemStellartech Research Corp.20060—
+4K062057U-Clip Device, Model NC65Medtronic Vascular20062—
+4K061260Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214Intuitive Surgical, Inc.20061541
+4K060391Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc.20061551
+5K252926Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical…Restore Robotics20260—
+5K240852da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)Intuitive Surgical, Inc.20250—
+5K243157AtriCure cryoICE BOX (ACM)AtriCure, Inc.20240—
+5K240376Electroporation System (N3000)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.20240—
+5K233866Senhance Surgical SystemAsensus Surgical, Inc.20240—
+5K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC20240—
+5K240723da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)Intuitive Surgical20241—
+5K233838Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint…Medtronic, Inc.20240—
+5K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc.2024116
+5K231224da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.202313—
+5K223095Senhance Surgical SystemAsensus Surgical, Inc.20231Class I
+5K2200238mm Monopolar Curved ScissorsIntuitive Surgical, Inc.202211
+5K200081NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20202—
+5K202571da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2020141
+5K192717da Vinci SP Surgical SystemIntuitive Surgical, Inc.202041
+5K200061HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1…Galil Medical, Inc.20200—
+5K192803da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical20200—
+5K193232Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with…Covidien, LLC20204—
+5K191526Cardioblate CryoFlex Surgical Ablation SystemMedtronic, Inc.20190—
+5K183153Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20199—
+5K180351EndoWrist Mercury Bipolar GrasperIntuitive Surgical, Inc.201802
+5K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2018219
+5K180138AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc.20184—
+5K180137AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation…AtriCure, Inc.20180—
+5K171120Senhance Surgical Robotic SystemTransenterix, Inc.201712—
+5K170875da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments…Intuitive Surgical, Inc.20170—
+5K171358Emprint SX Ablation Platform and AccessoriesCoviden, LLC20176—
+5K171426da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degreeIntuitive Surgical, Inc.20171—
+5K171294da Vinci X Surgical SystemIntuitive Surgical, Inc.20173110
+5K163105Emprint Ablation SystemCovidien, LLC2016133
+5K161271da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201613—
+5K152892da Vinci Xi Surgical SystemIntuitive Surgical201612—
+5K152337cryoFORM cryoICE cryoablation probeAtriCure, Inc.20162—
+5K152448da Vinci Single-Site Instrument and AccessoriesIntuitive Surgical, Inc.2016101
+5K151794da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201612—
+5K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+5K150419miraDry System MD4000Miramar Labs, Inc.201521
+5K150089NanoKnife SystemAngioDynamics, Inc.201581
+5K150284IS4000 da Vinci EndoWrist InstrumentsIntuitive Surgical, Inc.201508
+5K150837IS4000 Small Clip Applier, IS4000 Long Bipolar ForcepsIntuitive Surgical, Inc.201503
+5K14268312 mm Endoscopes and AccessoriesIntuitive Surgical, Inc.20141—
+5K142084Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.201411
+5K141075Single-Site Wristed Needle DriverIntuitive Surgical20141—
+5K141272Floshield 10MM Endoscopic Cannula and Blunt Obturator, Floshield 10MM Endoscopic…Minimmally Invasive Devices20144—
+5K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc.2014872
+5K140058Atricure Cryo Module SystemAtriCure, Inc.2014102
+5K133017Estech Cobra (R) Genesis Bipolar ClampEstech, Inc.20130—