510(k) Report

Devices descending from K993944

183 later devices reach Rita Model 1500 Electrosurgical Generator, Power Cord,Footswitch,Main Cable… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K142203Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc.20149—
+5K142441cryoICE croablation probeAtriCure, Inc.20141—
+5K130521Isolator Linear PenAtriCure, Inc.20133—
+5K123733Cardioblate Cryoflex Surgical Ablation SystemMedtronic, Inc.201315
+5K122611Coolrail Linear Pen Model McriAtriCure, Inc.20123—
+5K121767Cardioblate Gemini Surgical Ablation DeviceMedtronic, Inc.201221
+5K113475Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech201245
+5K111042Atricure Cryo ModuleAtriCure, Inc.201114—
+5K093203Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831, 60832, 60841Medtronic, Inc.20103—
+5K090721Cardioblate Maps Surgical Mapping, Ablation, Pacing and Sensing Device, Model 49205Medtronic20091—
+5K080287Oncobionic Bipolar ElectrodeAngioDynamics, Inc.20080—
+5K080202Oncobionic System with 6 Probe OutputOncobionics, Inc.2008111
+5K081082U-Clip Uni-Fire, Model M65Medtronic, Inc.20080—
+5K080376Oncobionic SystemOncobionic Incorporated2008111
+5K070311Cardioblate Gemini Surgical Ablation Device, Models 49260 and 49261Medtronic Vascular20071—
+5K062057U-Clip Device, Model NC65Medtronic Vascular20062—
+6K253656OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation Limited20250—
+6K250327OptaBlate Radiofrequency (RF) Generator SystemStryker Instruments20250—
+6K243157AtriCure cryoICE BOX (ACM)AtriCure, Inc.20240—
+6K222388swiftPro SystemEmblation, Ltd.20232—
+6K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical…Medtronic, Inc.20220—
+6K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20223—
+6K201265Disposable Microwave Therapeutic AntennasNanjing Eco Microwave System Co., Ltd.20214—
+6K201262Microwave Therapeutic SystemNanjing Eco Microwave System Co., Ltd.20214—
+6K200298ABI Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20212—
+6K203303Emprint SX Ablation Platform with Thermosphere TechnologyCovidien, LLC20200—
+6K200081NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20202—
+6K200003NP1 Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20201—
+6K200796Emprint Ablation System with Thermosphere TechnologyCovidien, LLC20203—
+6K200514Cardioblate Gemini-s Surgical Ablation DeviceMedtronic202011
+6K191526Cardioblate CryoFlex Surgical Ablation SystemMedtronic, Inc.20190—
+6K191601Valleylab FT10 Electrosurgical PlatformCovidien201911
+6K190151COBRA Fusion Ablation SystemAtriCure, Inc.20190—
+6K183065Coolrail Linear PenAtriCure, Inc.20182—
+6K180138AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc.20184—
+6K180137AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation…AtriCure, Inc.20180—
+6K163408Isolator Multifunctional Linear PenAtriCure, Inc.20172—
+6K152337cryoFORM cryoICE cryoablation probeAtriCure, Inc.20162—
+6K140058Atricure Cryo Module SystemAtriCure, Inc.2014102
+6K120857Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.20122—
+6K121451Cardioblate Maps Surgical Mapping, Ablation, Pacing , and Sensing DeviceMedtronic, Inc.20120—
+6K102329Nanoknife SystemAngioDynamics, Inc.2011101
+6K112072Atricure Cryo Module SystemAtriCure, Inc.201113—
+6K090869Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula…Medtronic Perfusion Systems20090—
+6K062821U-Clip DeviceMedtronic Neurosurgery20060—
+7K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console…Medinice S.A.20260—
+7K240376Electroporation System (N3000)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.20240—
+7K241827Microwave Ablation Generator (KY-2000A, KY-2100A)Canyon Medical, Inc.20240—
+7K241825Microwave Ablation AntennasCanyon Medical, Inc.20240—
+7K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC20240—
+7K240784Temperature Sensor Probe (ABL-18TP20)Varian Medical Systems, Inc.20240—
+7K240518swiftPro™ SystemEmblation Limited20241—
+7K233140Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)Hygea Medical Technology Co., Ltd.20240—
+7K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc.20232—
+7K232240Microwave Ablation System (BD-GT)Betters (Suzhou) Medical Co., Ltd.20231—
+7K232241Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818…Betters (Suzhou) Medical Co., Ltd.20231—
+7K223138AB1 Electrosurgical Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20231—
+7K221672Creo Electrosurgical System with NP1 InstrumentCreo Medical, Ltd.20230—
+7K220472NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20221—
+7K200697AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation…AtriCure, Inc.20202—
+7K190587Coolrail Linear PenAtriCure, Inc.20191—
+7K182565AtriCure cryoICE cryoSPHERE cryoablation probeAtriCure, Inc.20183—
+7K150089NanoKnife SystemAngioDynamics, Inc.201581
+7K142084Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.201411
+7K133672Reprocessed Harmonic Ace Shears Without Adaptive Tissue TechnologyStryker Sustainability Solutions20140—
+7K121507Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc.201211—
+8K252632Microwave Ablation DeviceNanjing Dewen Medical Technology Co., Ltd.20260—
+8K253771Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14…Nanjing Devin Medical Technology Co., Ltd.20260—
+8K250371cryoICE cryoXT cryoablation probe (cryoXT)AtriCure, Inc.20250—
+8K242983CROMA Electrosurgical Generator (PRD-EMR-050)Creo Medical, Ltd.20250—
+8K240503Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20241—
+8K233170cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe…AtriCure, Inc.20230—
+8K193162EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc.20190—
+8K183385NanoKnife SystemAngiodynamics201971
+9K253846Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe)…Hangzhou Ruidi Biotechnology, Ltd.20260—
+9K250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20250—
+9K242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15…AngioDynamics, Inc.20241—
+9K222001Irreversible Electroporation Ablation Generator, Irreversible Electroporation ProbeZhejiang Curaway Medical Technology Co., Ltd.20230—
+9K212871Aliya (TM) System, Aliya (TM) Generator, Aliya (TM) Needle, Aliya (TM) ElectrodeGalvanize Therapeutics, Inc.20222—
+10K253826Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20260—
+10K253198NanoKnife Generator (H78720300351US0)Angiodynamics20260—
+10K233884INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20241—