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
+4K171426da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degreeIntuitive Surgical, Inc.20171—
+4K171294da Vinci X Surgical SystemIntuitive Surgical, Inc.20173110
+4K161271da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201613—
+4K152892da Vinci Xi Surgical SystemIntuitive Surgical201612—
+4K152448da Vinci Single-Site Instrument and AccessoriesIntuitive Surgical, Inc.2016101
+4K151794da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201612—
+4K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+4K143203AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe…Medwaves Incorporated20150—
+4K150284IS4000 da Vinci EndoWrist InstrumentsIntuitive Surgical, Inc.201508
+4K150837IS4000 Small Clip Applier, IS4000 Long Bipolar ForcepsIntuitive Surgical, Inc.201503
+4K14268312 mm Endoscopes and AccessoriesIntuitive Surgical, Inc.20141—
+4K141075Single-Site Wristed Needle DriverIntuitive Surgical20141—
+4K141272Floshield 10MM Endoscopic Cannula and Blunt Obturator, Floshield 10MM Endoscopic…Minimmally Invasive Devices20144—
+4K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc.2014872
+4K133821Emprint Ablation SystemCovidien, LLC2014297
+4K123548The Artas SystemRestoration Robotics, Inc.201314
+4K123154Artas System From Restoration RoboticsRestoration Robotics, Inc.20130—
+4K123840Connect for DA Vinci Surgical System (S)Intuitive Surgical, Inc.20130—
+4K121921Intuitive Surgical Onsite for DA Vinci Surgical SystemsIntuitive Surgical, Inc.20120—
+4K113706Endowrist Stapler SystemIntuitive Surgical, Inc.201221
+4K121767Cardioblate Gemini Surgical Ablation DeviceMedtronic, Inc.201221
+4K112208Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc.20114312
+4K102329Nanoknife SystemAngioDynamics, Inc.2011101
+4K101581Intuitive Surgical DA Vinci S Surgical System with DA Vinci Connect & DA Vinci Onsite…Intuitive Surgical, Inc.20116—
+4K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc.20111042
+4K093203Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831, 60832, 60841Medtronic, Inc.20103—
+4K090721Cardioblate Maps Surgical Mapping, Ablation, Pacing and Sensing Device, Model 49205Medtronic20091—
+4K073112DA Vinci Sonicpro Cleaning System, Model 400253Intuitive Surgical, Inc.20085—
+5K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20262—
+5K251227da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+5K250442da Vinci Surgical System, IS5000Intuitive Surgical, Inc.20250—
+5K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc.20250—
+5K251213Da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+5K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20251—
+5K2514908 mm Assist Cannula; 12 mm Assist CannulaIntuitive Surgical, Inc.20250—
+5K242427da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.20250—
+5K2426108mm Monopolar Curved Scissors (470179)Iconocare Health20250—
+5K243582da Vinci SP Advanced Access Port Kit (432701)Intuitive Surgical, Inc.20250—
+5K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+5K240376Electroporation System (N3000)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.20240—
+5K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc.20240—
+5K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242—
+5K233838Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint…Medtronic, Inc.20240—
+5K230033Da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202312—
+5K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical…Medtronic, Inc.20220—
+5K210918da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20216—
+5K202968Da Vinci SP Surgical SystemIntuitive Surgical, Inc.202031
+5K200081NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20202—
+5K200061HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1…Galil Medical, Inc.20200—
+5K200514Cardioblate Gemini-s Surgical Ablation DeviceMedtronic202011
+5K193232Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with…Covidien, LLC20204—
+5K191529da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical202012—
+5K190081RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber…STERIS Corporation20194—
+5K191736da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30Intuitive Surgical20190—
+5K191601Valleylab FT10 Electrosurgical PlatformCovidien201911
+5K183153Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20199—
+5K181941Swift SystemEmblation, Ltd.20183—
+5K181517Senhance Surgical SystemTransenterix, Inc.201810—
+5K180163TransEnterix Senhance Surgical SystemTransenterix, Inc.201811—
+5K173358ARTAS SystemRestoration Robotics, Inc.20180—
+5K170879IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30…Intuitive Surgical, Inc.20170—
+5K171358Emprint SX Ablation Platform and AccessoriesCoviden, LLC20176—
+5K171388EndoWrist Stapler 45 System and Stapler 45 ReloadsIntuitive Surgical, Inc.20171—
+5K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site…Intuitive Surgical, Inc.20178—
+5K163105Emprint Ablation SystemCovidien, LLC2016133
+5K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.2016701
+5K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+5K150089NanoKnife SystemAngioDynamics, Inc.201581
+5K150705FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic…Minimally Invasive Devices, Inc.20153—
+5K124031DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc.2013103—
+5K130726DA Vinci Single-Site Permanent Cautery HookIntuitive Surgical, Inc.201327
+5K121451Cardioblate Maps Surgical Mapping, Ablation, Pacing , and Sensing DeviceMedtronic, Inc.20120—
+5K120215Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper, Single-Site Fundus…Intuitive Surgical, Inc.2012423
+6K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+6K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+6K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+6K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—
+6K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation Limited20250—
+6K241796TroCare TroKit Laparoscope Lens Wiper (CP000626)TroCare, LLC20242—
+6K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC20240—
+6K231798da Vinci SP Surgical SystemIntuitive Surgical, Inc.202311—
+6K222388swiftPro SystemEmblation, Ltd.20232—
+6K213943SmartSurgN Visualization SystemSmartsurgn Incorporated20221—
+6K220472NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20221—
+6K213710da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20222—
+6K212101da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20212—
+6K201265Disposable Microwave Therapeutic AntennasNanjing Eco Microwave System Co., Ltd.20214—
+6K211316da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202111
+6K202582Arthrex SynergyID Endoscopic Imaging SystemArthrex, Inc.20215—
+6K201262Microwave Therapeutic SystemNanjing Eco Microwave System Co., Ltd.20214—
+6K211595da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202101
+6K200298ABI Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20212—
+6K203303Emprint SX Ablation Platform with Thermosphere TechnologyCovidien, LLC20200—
+6K200003NP1 Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20201—
+6K200796Emprint Ablation System with Thermosphere TechnologyCovidien, LLC20203—
+6K200577RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber…STERIS Corporation20203—
+6K192292L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight CableStryker20191—
+6K191482Senhance Surgical SystemTransenterix, Inc.20198—
+6K183385NanoKnife SystemAngiodynamics201971
+6K183098Senhance Surgical SystemTransenterix, Inc.20180—