510(k) Report

Devices descending from K811390

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K153541Coldplay CryoBalloon® Ablation SystemC2 Therapeutics, Inc.20160—
+5K140585CTC Tcat (R)-Tplan (R) Surgical SystemCurexo Technology Corporation201410—
+5K140038Digimatch Orthodoc Robodoc Encore Surgical SystemCurexo Technology Corporation20140—
+5K131962DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.201422—
+5K131861DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc.201412480
+5K122532DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc.2013396
+5K130399Certus 140 Certusurggt Surgical ToolNeuwave Medical, Inc.20136—
+5K122217Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc.20128—
+5K123463Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc.20121482
+5K121878Cardioblate Cryoflex Surgical Ablation ProbesMedtronic, Inc.20122—
+5K113237Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc.201238—
+5K102329Nanoknife SystemAngioDynamics, Inc.2011101
+5K112263Monopolar Curved Scissors Tip Cover AccessoryIntuitive Surgical, Inc.2011271
+5K103428The Artas System From Restoration RoboticsRestoration Robotics, Inc.20113—
+5K101174Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2…AtriCure, Inc.20106—
+5K100501Multifunctional Linear PenAtriCure, Inc.20109—
+5K082497Intuitive Surgical Endowrist One Hot Shears InstrumentIntuitive Surgical, Inc.200923—
+5K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc.200921125
+5K081207Intuitive Surgical DA Vinci S Surgical System, Model IS2000, with DA Vinci Connect and…Intuitive Surgical, Inc.20087—
+5K082279Epicor Ablation Control System, Model Acs-US-2, Acs-Eur-2St Jude Medical20080—
+5K080509Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device…Medtronic, Inc.200810—
+5K080291Intuitive Surgical DA Vinci Endoscopic Instruments and Control System and Endowrist…Intuitive Surgical, Inc.200801
+5K073605Atricure Coolrail Linear PenAtriCure, Inc.200813—
+5K070947Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments and Endowrist…Intuitive Surgical, Inc.200801
+5K072627Intuitive Surgical DA Vinci and DA Vinci S Surgical System and Endoscopic Instruments…Intuitive Surgical, Inc.20080—
+5K070288Cardioblate Monopolar Pen, 60813, Cardioblate Monopolar XL, 60814Medtronic Vascular20072—
+5K062539Ncontact Coagulation System KitNcontact Surgical, Inc.20060—
+5K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc.20062244
+5K062140Surgifrost XL Cryosurgical Device, Model 60SFXL; Cryosurgical Console, Model 65CS1Cryocath Technologies, Inc.20061—
+5K061593Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1AtriCure, Inc.2006131
+5K061260Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214Intuitive Surgical, Inc.20061541
+5K060391Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc.20061551
+5K060400Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate BP2 Surgical Ablation…Medtronic, Inc.200614—
+6K252926Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical…Restore Robotics20260—
+6K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc.20250—
+6K240852da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)Intuitive Surgical, Inc.20250—
+6K240376Electroporation System (N3000)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.20240—
+6K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc.20240—
+6K233866Senhance Surgical SystemAsensus Surgical, Inc.20240—
+6K240723da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)Intuitive Surgical20241—
+6K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc.2024116
+6K231738NEUWAVE™ Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20230—
+6K231224da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.202313—
+6K223095Senhance Surgical SystemAsensus Surgical, Inc.20231Class I
+6K2200238mm Monopolar Curved ScissorsIntuitive Surgical, Inc.202211
+6K202571da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2020141
+6K192717da Vinci SP Surgical SystemIntuitive Surgical, Inc.202041
+6K192803da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical20200—
+6K192125Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenAtriCure, Inc.20191—
+6K190194C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2…Pentax Medical, A Division of Pentax of America, Inc.20193—
+6K190623Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation DeviceMedtronic20190—
+6K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device…Medtronic20182—
+6K173756Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc.20183—
+6K180351EndoWrist Mercury Bipolar GrasperIntuitive Surgical, Inc.201802
+6K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2018219
+6K171120Senhance Surgical Robotic SystemTransenterix, Inc.201712—
+6K170875da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments…Intuitive Surgical, Inc.20170—
+6K171426da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degreeIntuitive Surgical, Inc.20171—
+6K171294da Vinci X Surgical SystemIntuitive Surgical, Inc.20173110
+6K161271da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201613—
+6K152892da Vinci Xi Surgical SystemIntuitive Surgical201612—
+6K152448da Vinci Single-Site Instrument and AccessoriesIntuitive Surgical, Inc.2016101
+6K151794da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201612—
+6K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+6K143203AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe…Medwaves Incorporated20150—
+6K150089NanoKnife SystemAngioDynamics, Inc.201581
+6K150284IS4000 da Vinci EndoWrist InstrumentsIntuitive Surgical, Inc.201508
+6K150837IS4000 Small Clip Applier, IS4000 Long Bipolar ForcepsIntuitive Surgical, Inc.201503
+6K14268312 mm Endoscopes and AccessoriesIntuitive Surgical, Inc.20141—
+6K141075Single-Site Wristed Needle DriverIntuitive Surgical20141—
+6K141272Floshield 10MM Endoscopic Cannula and Blunt Obturator, Floshield 10MM Endoscopic…Minimmally Invasive Devices20144—
+6K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc.2014872
+6K133821Emprint Ablation SystemCovidien, LLC2014297
+6K130521Isolator Linear PenAtriCure, Inc.20133—
+6K123733Cardioblate Cryoflex Surgical Ablation SystemMedtronic, Inc.201315
+6K123548The Artas SystemRestoration Robotics, Inc.201314
+6K123154Artas System From Restoration RoboticsRestoration Robotics, Inc.20130—
+6K123840Connect for DA Vinci Surgical System (S)Intuitive Surgical, Inc.20130—
+6K121921Intuitive Surgical Onsite for DA Vinci Surgical SystemsIntuitive Surgical, Inc.20120—
+6K113706Endowrist Stapler SystemIntuitive Surgical, Inc.201221
+6K122611Coolrail Linear Pen Model McriAtriCure, Inc.20123—
+6K121767Cardioblate Gemini Surgical Ablation DeviceMedtronic, Inc.201221
+6K113475Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech201245
+6K112208Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc.20114312
+6K101581Intuitive Surgical DA Vinci S Surgical System with DA Vinci Connect & DA Vinci Onsite…Intuitive Surgical, Inc.20116—
+6K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc.20111042
+6K093203Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831, 60832, 60841Medtronic, Inc.20103—
+6K090721Cardioblate Maps Surgical Mapping, Ablation, Pacing and Sensing Device, Model 49205Medtronic20091—
+6K073112DA Vinci Sonicpro Cleaning System, Model 400253Intuitive Surgical, Inc.20085—
+6K081082U-Clip Uni-Fire, Model M65Medtronic, Inc.20080—
+6K062057U-Clip Device, Model NC65Medtronic Vascular20062—
+7K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20262—
+7K251227da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+7K250442da Vinci Surgical System, IS5000Intuitive Surgical, Inc.20250—
+7K251213Da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+7K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20251—
+7K2514908 mm Assist Cannula; 12 mm Assist CannulaIntuitive Surgical, Inc.20250—
+7K242427da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.20250—
+7K2426108mm Monopolar Curved Scissors (470179)Iconocare Health20250—
+7K243582da Vinci SP Advanced Access Port Kit (432701)Intuitive Surgical, Inc.20250—