510(k) Report

Devices descending from K984552

1,174 later devices reach Cool-Tip RF System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120116Serf Ablation System Serf Ablation NeedleThermedical20120—
+1K072870Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc.200811—
+1K072261Finesse SystemPrimaeva Medical, Inc.2007100—
+1K070356Medwaves Microwave Coagulation/Ablation SystemMedwaves Incorporated20072—
+1K070446Cool-Tip Switching Controller, CTSW ControlValleylab,A Division of Tyco Healthcare Group LP20072—
+1K070101Uniblate Electrosurgical DeviceRita Medical Systems, Inc.200722—
+1K062935Habib 4X LaparoscopicRita Medical Systems20061—
+1K052796Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab200656—
+1K052919Microsulis Tissue Ablation SystemMicrosulis Americas, Inc.200615—
+1K042216Cool-Tip RF Ablation SystemValleylab200475—
+1K040763Resect Medical Inline BI-Polar RF Linear Coagulation DeviceResect Medical, Inc.20040—
+1K000944Thermage Thermacool SystemThermage, Inc.20001,069—
+2K223135AblatePal Radiofrequency Ablation SystemCompal Electronics, Inc.20230—
+2K203150Cool-tip RF Ablation System E SeriesCovidien, LLC20220—
+2K192715CRF Radiofrequency Ablation SystemCambridge Interventional, LLC20200—
+2K190052Radio Frequency Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20192—
+2K181941Swift SystemEmblation, Ltd.20183—
+2K163450VIVA combo RF SystemStarmed Co., Ltd.20177—
+2K143203AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe…Medwaves Incorporated20150—
+2K130689Symphony RF GeneratorThermigen, Inc.201311—
+2K100744Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc.201039—
+2K083157HS AmicaH.S Hospital Service S.P.A20094—
+2K082391Primaeva Medical Renesis SystemPrimaeva Medical, Inc.200959—
+2K082819Dermatologic Treatment System (DTS) G2Miramar Labs, Inc.200910—
+2K083537Modification to Medwaves Microwave Coagulation/Ablation SystemMedwaves Incorporated20091—
+2K082962Tivamed Cooled RF System, Model 78001Tivamed, Inc.20087—
+2K080451Uniblate Electrosurgical DeviceAngioDynamics, Inc.20088—
+2K080287Oncobionic Bipolar ElectrodeAngioDynamics, Inc.20080—
+2K080376Oncobionic SystemOncobionic Incorporated2008111
+2K080145Primaeva Medical SystemPrimaeva Medical, Inc.200899—
+2K073687Habib Laparoscopic HexablateEmcision, Ltd.20080—
+2K053290Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab200650—
+2K043402Thermage Thermacool SystemThermage, Inc.2005124—
+2K033942Thermage Thermacool SystemThermage, Inc.2004527—
+2K021402Thermage Thermacool TC SystemThermage, Inc.2002789—
+2K022266Aurora SRSyneron Medical, Ltd.2002705—
+2K021149Aurora DSSyneron Medical, Ltd.2002750—
+2K013639Thermage Thermacool TC SystemThermage, Inc.2002799—
+2K013034Modification to: Thermacool IiaThermage, Inc.2001800—
+3K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation Limited20250—
+3K240758Radiofrequency Generator System, Cura RF ElectrodeZhejiang Curaway Medical Technology Co., Ltd.20240—
+3K240932HybridTherm SystemErbe Elektromedizin GmbH20241—
+3K240480IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation…Varian Medical Systems, Inc.20240—
+3K233705CellFX Percutaneous Electrode System (SYS3000)Pulse Biosciences, Inc.20241—
+3K222388swiftPro SystemEmblation, Ltd.20232—
+3K223272SurBlate Ablation SystemMima-Pro Scientific, Inc.20230—
+3K183538VIVA combo RF SystemStarmed Co., Ltd.20192—
+3K182497OsteoCool RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20195—
+3K172012star RF Electrode, VIVA RF ElectrodeStarmed Co., Ltd.20181—
+3K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+3K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+3K163118FLEX Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20170—
+3K161949OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc.20177—
+3K162547Viveve SystemViveve, Inc.20166—
+3K161043Profound SystemSyneron Candela Corporation20160—
+3K161661Thermi RF AccessoriesThermi20163—
+3K160936Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc.20165—
+3K151793InMode RF SystemInmode MD, Ltd.20161—
+3K150019TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc.20160—
+3K150112HS Amica Devices FamilyH.S Hospital Service S.P.A20152—
+3K130501IntensifEndymed Medical, Ltd.201457—
+3K130399Certus 140 Certusurggt Surgical ToolNeuwave Medical, Inc.20136—
+3K121481Infini Radiofrequency SystemLutronic Corporation201357—
+3K122217Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc.20128—
+3K113237Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc.201238—
+3K102329Nanoknife SystemAngioDynamics, Inc.2011101
+3K103014Miradry SystemMiramar Labs, Inc.201152
+3K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+3K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+3K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+3K083352Veinwave, TC3000Newlands Clinical Trials, Ltd.20094—
+3K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+3K082956Alpha Orthopaedics AT2 SystemAlpha Orthopaedics20081—
+3K072687Valleylab Microwave Ablation GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison200842—
+3K072849Modification to Thermage Thermacool SystemThermage, Inc.200820—
+3K052936Thermage Thermacool SystemThermage, Inc.2007103—
+3K070004AccentAlma Lasers, Ltd.2007181—
+3K060948Portrait PSR3Rhytec Incorporated20061101
+3K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+3K051710Thermage Thermacool Coupling FluidThermage, Inc.200556—
+3K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+3K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+3K040135Thermage Thermacool SystemThermage, Inc.2004496—
+3K031489PitangaSyneron Medical, Ltd.20030—
+3K032088Modification to Thermacool TC SystemThermage, Inc.2003131—
+3K031988Aurora DSSyneron Medical, Ltd.2003450—
+3K031993Aurora SRSyneron Medical, Ltd.2003303—
+3K030426Omnilux RedPhoto Therapeutics Limited2003563—
+3K031046Thermacool TC SystemThermage, Inc.200322—
+3K023111Gyrus Plasma Skin Resurfacing SystemGyrus Medical, Inc.20030—
+3K024064Polaris DSSyneron Medical, Ltd.2003681—
+3K030142Thermacool TC SystemThermage, Inc.2003773—
+4K251108Erbe ESU Model VIO® 3n with AccessoriesErbe Elektromedizin GmbH20250—
+4K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+4K240376Electroporation System (N3000)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.20240—
+4K240782CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G…Pulse Biosciences, Inc.20240—
+4K240070Profound MatrixCandela Corporation20240—
+4K240518swiftPro™ SystemEmblation Limited20241—
+4K233830OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20241—
+4K234140VIVA combo RF System (VIVA combo RF System)Starmed Co., Ltd.20241—