510(k) Report

Devices descending from K964971

394 later devices reach Cryogen Cryosurgical System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K061593Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1AtriCure, Inc.2006131
+6K061260Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214Intuitive Surgical, Inc.20061541
+6K060391Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc.20061551
+6K060400Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate BP2 Surgical Ablation…Medtronic, Inc.200614—
+7K252926Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical…Restore Robotics20260—
+7K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc.20250—
+7K240852da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)Intuitive Surgical, Inc.20250—
+7K240376Electroporation System (N3000)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.20240—
+7K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc.20240—
+7K233866Senhance Surgical SystemAsensus Surgical, Inc.20240—
+7K240723da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)Intuitive Surgical20241—
+7K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc.2024116
+7K231738NEUWAVE™ Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20230—
+7K231224da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.202313—
+7K223095Senhance Surgical SystemAsensus Surgical, Inc.20231Class I
+7K2200238mm Monopolar Curved ScissorsIntuitive Surgical, Inc.202211
+7K202571da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2020141
+7K192717da Vinci SP Surgical SystemIntuitive Surgical, Inc.202041
+7K192803da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical20200—
+7K192125Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenAtriCure, Inc.20191—
+7K190623Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation DeviceMedtronic20190—
+7K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device…Medtronic20182—
+7K173756Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc.20183—
+7K180351EndoWrist Mercury Bipolar GrasperIntuitive Surgical, Inc.201802
+7K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2018219
+7K171120Senhance Surgical Robotic SystemTransenterix, Inc.201712—
+7K170875da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments…Intuitive Surgical, Inc.20170—
+7K171426da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degreeIntuitive Surgical, Inc.20171—
+7K171294da Vinci X Surgical SystemIntuitive Surgical, Inc.20173110
+7K161271da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201613—
+7K152892da Vinci Xi Surgical SystemIntuitive Surgical201612—
+7K152448da Vinci Single-Site Instrument and AccessoriesIntuitive Surgical, Inc.2016101
+7K151794da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201612—
+7K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+7K143203AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe…Medwaves Incorporated20150—
+7K150089NanoKnife SystemAngioDynamics, Inc.201581
+7K150284IS4000 da Vinci EndoWrist InstrumentsIntuitive Surgical, Inc.201508
+7K150837IS4000 Small Clip Applier, IS4000 Long Bipolar ForcepsIntuitive Surgical, Inc.201503
+7K14268312 mm Endoscopes and AccessoriesIntuitive Surgical, Inc.20141—
+7K142203Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc.20149—
+7K142441cryoICE croablation probeAtriCure, Inc.20141—
+7K141075Single-Site Wristed Needle DriverIntuitive Surgical20141—
+7K141272Floshield 10MM Endoscopic Cannula and Blunt Obturator, Floshield 10MM Endoscopic…Minimmally Invasive Devices20144—
+7K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc.2014872
+7K133821Emprint Ablation SystemCovidien, LLC2014297
+7K130521Isolator Linear PenAtriCure, Inc.20133—
+7K123733Cardioblate Cryoflex Surgical Ablation SystemMedtronic, Inc.201315
+7K123548The Artas SystemRestoration Robotics, Inc.201314
+7K123154Artas System From Restoration RoboticsRestoration Robotics, Inc.20130—
+7K123840Connect for DA Vinci Surgical System (S)Intuitive Surgical, Inc.20130—
+7K121921Intuitive Surgical Onsite for DA Vinci Surgical SystemsIntuitive Surgical, Inc.20120—
+7K113706Endowrist Stapler SystemIntuitive Surgical, Inc.201221
+7K122611Coolrail Linear Pen Model McriAtriCure, Inc.20123—
+7K121767Cardioblate Gemini Surgical Ablation DeviceMedtronic, Inc.201221
+7K113475Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech201245
+7K112208Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc.20114312
+7K111042Atricure Cryo ModuleAtriCure, Inc.201114—
+7K101581Intuitive Surgical DA Vinci S Surgical System with DA Vinci Connect & DA Vinci Onsite…Intuitive Surgical, Inc.20116—
+7K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc.20111042
+7K093203Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831, 60832, 60841Medtronic, Inc.20103—
+7K090721Cardioblate Maps Surgical Mapping, Ablation, Pacing and Sensing Device, Model 49205Medtronic20091—
+7K073112DA Vinci Sonicpro Cleaning System, Model 400253Intuitive Surgical, Inc.20085—
+7K081082U-Clip Uni-Fire, Model M65Medtronic, Inc.20080—
+7K062057U-Clip Device, Model NC65Medtronic Vascular20062—
+8K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20262—
+8K251227da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+8K250442da Vinci Surgical System, IS5000Intuitive Surgical, Inc.20250—
+8K251213Da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+8K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20251—
+8K2514908 mm Assist Cannula; 12 mm Assist CannulaIntuitive Surgical, Inc.20250—
+8K242427da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.20250—
+8K2426108mm Monopolar Curved Scissors (470179)Iconocare Health20250—
+8K243582da Vinci SP Advanced Access Port Kit (432701)Intuitive Surgical, Inc.20250—
+8K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+8K243157AtriCure cryoICE BOX (ACM)AtriCure, Inc.20240—
+8K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242—
+8K233838Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint…Medtronic, Inc.20240—
+8K230033Da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202312—
+8K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical…Medtronic, Inc.20220—
+8K210918da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20216—
+8K202968Da Vinci SP Surgical SystemIntuitive Surgical, Inc.202031
+8K200081NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20202—
+8K200061HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1…Galil Medical, Inc.20200—
+8K200514Cardioblate Gemini-s Surgical Ablation DeviceMedtronic202011
+8K193232Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with…Covidien, LLC20204—
+8K191529da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical202012—
+8K191526Cardioblate CryoFlex Surgical Ablation SystemMedtronic, Inc.20190—
+8K190081RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber…STERIS Corporation20194—
+8K191736da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30Intuitive Surgical20190—
+8K191601Valleylab FT10 Electrosurgical PlatformCovidien201911
+8K183153Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20199—
+8K183385NanoKnife SystemAngiodynamics201971
+8K190151COBRA Fusion Ablation SystemAtriCure, Inc.20190—
+8K183065Coolrail Linear PenAtriCure, Inc.20182—
+8K181941Swift SystemEmblation, Ltd.20183—
+8K181517Senhance Surgical SystemTransenterix, Inc.201810—
+8K180163TransEnterix Senhance Surgical SystemTransenterix, Inc.201811—
+8K173358ARTAS SystemRestoration Robotics, Inc.20180—
+8K180138AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc.20184—
+8K180137AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation…AtriCure, Inc.20180—