510(k) Report

Devices descending from K052796

56 later devices reach Cool-Tip RF Generator, Cool-Tip RF System Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203150Cool-tip RF Ablation System E SeriesCovidien, LLC20220—
+1K190052Radio Frequency Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20192—
+1K120116Serf Ablation System Serf Ablation NeedleThermedical20120—
+1K100744Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc.201039—
+1K080451Uniblate Electrosurgical DeviceAngioDynamics, Inc.20088—
+1K070446Cool-Tip Switching Controller, CTSW ControlValleylab,A Division of Tyco Healthcare Group LP20072—
+2K240480IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation…Varian Medical Systems, Inc.20240—
+2K233705CellFX Percutaneous Electrode System (SYS3000)Pulse Biosciences, Inc.20241—
+2K192715CRF Radiofrequency Ablation SystemCambridge Interventional, LLC20200—
+2K182497OsteoCool RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20195—
+2K163118FLEX Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20170—
+2K161949OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc.20177—
+2K160936Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc.20165—
+2K130399Certus 140 Certusurggt Surgical ToolNeuwave Medical, Inc.20136—
+2K122217Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc.20128—
+2K113237Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc.201238—
+3K240782CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G…Pulse Biosciences, Inc.20240—
+3K233830OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20241—
+3K231738NEUWAVE™ Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20230—
+3K223303Spinery™ RF Ablation SystemAxon Spine Medical System20230—
+3K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceStryker Corporation20222—
+3K192406AveCure BT Microwave Ablation SystemMedwaves, Inc.20200—
+3K173756Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc.20183—
+3K143203AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe…Medwaves Incorporated20150—
+3K133821Emprint Ablation SystemCovidien, LLC2014297
+4K253656OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K250327OptaBlate Radiofrequency (RF) Generator SystemStryker Instruments20250—
+4K233838Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint…Medtronic, Inc.20240—
+4K200081NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20202—
+4K200061HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1…Galil Medical, Inc.20200—
+4K193232Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with…Covidien, LLC20204—
+4K183153Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20199—
+4K181941Swift SystemEmblation, Ltd.20183—
+4K171358Emprint SX Ablation Platform and AccessoriesCoviden, LLC20176—
+4K163105Emprint Ablation SystemCovidien, LLC2016133
+5K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation Limited20250—
+5K222388swiftPro SystemEmblation, Ltd.20232—
+5K220472NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20221—
+5K201265Disposable Microwave Therapeutic AntennasNanjing Eco Microwave System Co., Ltd.20214—
+5K201262Microwave Therapeutic SystemNanjing Eco Microwave System Co., Ltd.20214—
+5K200298ABI Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20212—
+5K203303Emprint SX Ablation Platform with Thermosphere TechnologyCovidien, LLC20200—
+5K200003NP1 Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20201—
+5K200796Emprint Ablation System with Thermosphere TechnologyCovidien, LLC20203—
+6K241827Microwave Ablation Generator (KY-2000A, KY-2100A)Canyon Medical, Inc.20240—
+6K241825Microwave Ablation AntennasCanyon Medical, Inc.20240—
+6K240784Temperature Sensor Probe (ABL-18TP20)Varian Medical Systems, Inc.20240—
+6K240518swiftPro™ SystemEmblation Limited20241—
+6K233140Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)Hygea Medical Technology Co., Ltd.20240—
+6K232240Microwave Ablation System (BD-GT)Betters (Suzhou) Medical Co., Ltd.20231—
+6K232241Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818…Betters (Suzhou) Medical Co., Ltd.20231—
+6K223138AB1 Electrosurgical Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20231—
+6K221672Creo Electrosurgical System with NP1 InstrumentCreo Medical, Ltd.20230—
+7K252632Microwave Ablation DeviceNanjing Dewen Medical Technology Co., Ltd.20260—
+7K253771Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14…Nanjing Devin Medical Technology Co., Ltd.20260—
+7K242983CROMA Electrosurgical Generator (PRD-EMR-050)Creo Medical, Ltd.20250—