510(k) Report

Devices descending from K965182

79 later devices reach RFG-3CF through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081729Modification to GFX Nerve Ablation SystemBioform Medical, Inc.20080—
+1K063753GFX Nerve Ablation SystemAci, Inc.20071—
+1K021329Rita SystemRita Medical Systems200276—
+2K120116Serf Ablation System Serf Ablation NeedleThermedical20120—
+2K042216Cool-Tip RF Ablation SystemValleylab200475—
+3K223135AblatePal Radiofrequency Ablation SystemCompal Electronics, Inc.20230—
+3K163450VIVA combo RF SystemStarmed Co., Ltd.20177—
+3K083157HS AmicaH.S Hospital Service S.P.A20094—
+3K070446Cool-Tip Switching Controller, CTSW ControlValleylab,A Division of Tyco Healthcare Group LP20072—
+3K053290Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab200650—
+3K052796Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab200656—
+4K240758Radiofrequency Generator System, Cura RF ElectrodeZhejiang Curaway Medical Technology Co., Ltd.20240—
+4K240932HybridTherm SystemErbe Elektromedizin GmbH20241—
+4K223272SurBlate Ablation SystemMima-Pro Scientific, Inc.20230—
+4K203150Cool-tip RF Ablation System E SeriesCovidien, LLC20220—
+4K192715CRF Radiofrequency Ablation SystemCambridge Interventional, LLC20200—
+4K190052Radio Frequency Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20192—
+4K183538VIVA combo RF SystemStarmed Co., Ltd.20192—
+4K172012star RF Electrode, VIVA RF ElectrodeStarmed Co., Ltd.20181—
+4K150019TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc.20160—
+4K150112HS Amica Devices FamilyH.S Hospital Service S.P.A20152—
+4K100744Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc.201039—
+4K072687Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison200842—
+4K080451Uniblate Electrosurgical DeviceAngioDynamics, Inc.20088—
+5K251108Erbe ESU Model VIO® 3n with AccessoriesErbe Elektromedizin GmbH20250—
+5K240480IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation…Varian Medical Systems, Inc.20240—
+5K233705CellFX Percutaneous Electrode System (SYS3000)Pulse Biosciences, Inc.20241—
+5K234140VIVA combo RF System (VIVA combo RF System)Starmed Co., Ltd.20241—
+5K182605HS AMICA devices familyH.S Hospital Service S.P.A20191—
+5K182497OsteoCool RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20195—
+5K163118FLEX Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20170—
+5K161949OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc.20177—
+5K160936Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc.20165—
+5K141785Micro Thermx Microwave Ablation System and AccessoriesBsd Medical Corp.20150—
+5K133821Emprint Ablation SystemCovidien, LLC2014297
+5K130399Certus 140 Certusurggt Surgical ToolNeuwave Medical, Inc.20136—
+5K122217Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc.20128—
+5K113237Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc.201238—
+6K252833VIVA combo RF SystemStarmed Co., Ltd.20260—
+6K240782CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G…Pulse Biosciences, Inc.20240—
+6K233838Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint…Medtronic, Inc.20240—
+6K233830OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20241—
+6K232072Amica-Gen Agn-H-1.3, Amica-Gen Agn 3.3, Amica-Probe 17G & 18GH.S Hospital Service S.P.A20240—
+6K231738NEUWAVE™ Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20230—
+6K223303Spinery™ RF Ablation SystemAxon Spine Medical System20230—
+6K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceStryker Corporation20222—
+6K192406AveCure BT Microwave Ablation SystemMedwaves, Inc.20200—
+6K200061HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1…Galil Medical, Inc.20200—
+6K193232Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with…Covidien, LLC20204—
+6K183153Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20199—
+6K173756Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc.20183—
+6K181941Swift SystemEmblation, Ltd.20183—
+6K171358Emprint SX Ablation Platform and AccessoriesCoviden, LLC20176—
+6K163105Emprint Ablation SystemCovidien, LLC2016133
+6K143203AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe…Medwaves Incorporated20150—
+7K253656OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation Limited20250—
+7K250327OptaBlate Radiofrequency (RF) Generator SystemStryker Instruments20250—
+7K222388swiftPro SystemEmblation, Ltd.20232—
+7K201265Disposable Microwave Therapeutic AntennasNanjing Eco Microwave System Co., Ltd.20214—
+7K201262Microwave Therapeutic SystemNanjing Eco Microwave System Co., Ltd.20214—
+7K200298ABI Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20212—
+7K203303Emprint SX Ablation Platform with Thermosphere TechnologyCovidien, LLC20200—
+7K200081NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20202—
+7K200003NP1 Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20201—
+7K200796Emprint Ablation System with Thermosphere TechnologyCovidien, LLC20203—
+8K241827Microwave Ablation Generator (KY-2000A, KY-2100A)Canyon Medical, Inc.20240—
+8K241825Microwave Ablation AntennasCanyon Medical, Inc.20240—
+8K240784Temperature Sensor Probe (ABL-18TP20)Varian Medical Systems, Inc.20240—
+8K240518swiftPro™ SystemEmblation Limited20241—
+8K233140Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)Hygea Medical Technology Co., Ltd.20240—
+8K232240Microwave Ablation System (BD-GT)Betters (Suzhou) Medical Co., Ltd.20231—
+8K232241Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818…Betters (Suzhou) Medical Co., Ltd.20231—
+8K223138AB1 Electrosurgical Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20231—
+8K221672Creo Electrosurgical System with NP1 InstrumentCreo Medical, Ltd.20230—
+8K220472NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20221—
+9K252632Microwave Ablation DeviceNanjing Dewen Medical Technology Co., Ltd.20260—
+9K253771Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14…Nanjing Devin Medical Technology Co., Ltd.20260—
+9K242983CROMA Electrosurgical Generator (PRD-EMR-050)Creo Medical, Ltd.20250—