510(k) Report

Devices descending from K980430

108 later devices reach Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080771Top Neuropole Needle, Model SH, BL, SC, TCTop Corp.20084—
+1K050084Cosman RF Lesion Generator, Model RFG-1A; Cosman Tew Trigeminal Electrode Kit; Cosman…Cosman Medical, Inc.2005203
+1K042375SMK, CX, Cxe, RCNTechnomed Europe200412—
+1K041021RF Introduction CannulaEpimed International, Inc.200442
+1K034012Smith & Nephew RF Denervation Probes & RF CannulaeSmith & Nephew, Inc.2004153
+1K021329Rita SystemRita Medical Systems200276—
+1K021942Radionics Pole NeedlesRadionics, A Division of Tyco Healthcare Group LP200215—
+2K253907Disposable Radiofrequency CannulaAbbott Medical20260—
+2K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp.20250—
+2K183177Nitinol Thermocouple (TCN) ElectrodeBoston Scientific Corporation201907
+2K120116Serf Ablation System Serf Ablation NeedleThermedical20120—
+2K102566Owl CannulaeDiros Technology, Inc.20113—
+2K082051Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc.20087—
+2K082012Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc.20083—
+2K071300Modification to Smith & Nephew RF Denervation Probes & RF CannulaeSmith & Nephew, Inc.20070—
+2K063467Smith & Nephew RF CannulaeSmith & Nephew, Inc.20062—
+2K060397RF Lesion Cannula, RF Thermolesion Cannula, Thermolesion Cannula, X-Ray Contrast…PAJUNK GmbH Medizintechnologie20060—
+2K060799Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc.20069—
+2K053415Lesionpoint RF CannulaCosman Medical, Inc.200610—
+2K042216Cool-Tip RF Ablation SystemValleylab200475—
+2K040565Physician Industries Radiofrequency Ablation NeedlePhysician Industries, Inc.20040—
+3K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit…Boston Scientific Neuromodulation Corporation20250—
+3K231675OneRF Ablation SystemNeuroone Medical Technologies Corp.20231—
+3K223135AblatePal Radiofrequency Ablation SystemCompal Electronics, Inc.20230—
+3K163450VIVA combo RF SystemStarmed Co., Ltd.20177—
+3K150371Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRHDiros Technology, Inc.20150—
+3K141586Owl CannulaeDiros Technology, Inc.20142—
+3K123178Stryker Venom Electrodes and CannulaeStryker Instruments, Instruments Div.20132—
+3K111576NT 2000 Lesioning GeneratorNeuro Therm, Inc.201134
+3K083157HS AmicaH.S Hospital Service S.P.A20094—
+3K090955Smith & Nephew RF CannulateSmith & Nephew, Inc.200911
+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—
+4K232632Racz Neurostat RF GeneratorEpimed International20240—
+4K220122APEX 6Rf Innovations, Inc.20230—
+4K223272SurBlate Ablation SystemMima-Pro Scientific, Inc.20230—
+4K203150Cool-tip RF Ablation System E SeriesCovidien, LLC20220—
+4K201610IonicRF GeneratorAbbott Medical20200—
+4K191293LCCS VC-S RF CannulaLccs Products Limited20200—
+4K192715CRF Radiofrequency Ablation SystemCambridge Interventional, LLC20200—
+4K190052Radio Frequency Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20192—
+4K190256Rulo Radiofrequency Lesion ProbeEpimed International, Inc.20190—
+4K183538VIVA combo RF SystemStarmed Co., Ltd.20192—
+4K172012star RF Electrode, VIVA RF ElectrodeStarmed Co., Ltd.20181—
+4K170242MultiGen™ 2 RF Generator SystemStryker Corporation20170—
+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—