510(k) Report

Devices descending from K053290

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150019TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc.20160—
+1K150112HS Amica Devices FamilyH.S Hospital Service S.P.A20152—
+1K120116Serf Ablation System Serf Ablation NeedleThermedical20120—
+1K100744Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc.201039—
+1K072687Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison200842—
+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—
+2K203150Cool-tip RF Ablation System E SeriesCovidien, LLC20220—
+2K192715CRF Radiofrequency Ablation SystemCambridge Interventional, LLC20200—
+2K182605HS AMICA devices familyH.S Hospital Service S.P.A20191—
+2K163118FLEX Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20170—
+2K160936Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc.20165—
+2K141785Micro Thermx Microwave Ablation System and AccessoriesBsd Medical Corp.20150—
+2K133821Emprint Ablation SystemCovidien, LLC2014297
+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—
+3K233838Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint…Medtronic, Inc.20240—
+3K232072Amica-Gen Agn-H-1.3, Amica-Gen Agn 3.3, Amica-Probe 17G & 18GH.S Hospital Service S.P.A20240—
+3K231738NEUWAVE™ Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20230—
+3K200061HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1…Galil Medical, Inc.20200—
+3K193232Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with…Covidien, LLC20204—
+3K183153Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20199—
+3K173756Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc.20183—
+3K181941Swift SystemEmblation, Ltd.20183—
+3K171358Emprint SX Ablation Platform and AccessoriesCoviden, LLC20176—
+3K163105Emprint Ablation SystemCovidien, LLC2016133
+3K143203AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe…Medwaves Incorporated20150—
+4K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation Limited20250—
+4K222388swiftPro SystemEmblation, Ltd.20232—
+4K201265Disposable Microwave Therapeutic AntennasNanjing Eco Microwave System Co., Ltd.20214—
+4K201262Microwave Therapeutic SystemNanjing Eco Microwave System Co., Ltd.20214—
+4K200298ABI Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20212—
+4K203303Emprint SX Ablation Platform with Thermosphere TechnologyCovidien, LLC20200—
+4K200081NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20202—
+4K200003NP1 Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20201—
+4K200796Emprint Ablation System with Thermosphere TechnologyCovidien, LLC20203—
+5K241827Microwave Ablation Generator (KY-2000A, KY-2100A)Canyon Medical, Inc.20240—
+5K241825Microwave Ablation AntennasCanyon Medical, Inc.20240—
+5K240784Temperature Sensor Probe (ABL-18TP20)Varian Medical Systems, Inc.20240—
+5K240518swiftPro™ SystemEmblation Limited20241—
+5K233140Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)Hygea Medical Technology Co., Ltd.20240—
+5K232240Microwave Ablation System (BD-GT)Betters (Suzhou) Medical Co., Ltd.20231—
+5K232241Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818…Betters (Suzhou) Medical Co., Ltd.20231—
+5K223138AB1 Electrosurgical Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20231—
+5K221672Creo Electrosurgical System with NP1 InstrumentCreo Medical, Ltd.20230—
+5K220472NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20221—
+6K252632Microwave Ablation DeviceNanjing Dewen Medical Technology Co., Ltd.20260—
+6K253771Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14…Nanjing Devin Medical Technology Co., Ltd.20260—
+6K242983CROMA Electrosurgical Generator (PRD-EMR-050)Creo Medical, Ltd.20250—