510(k) Report

Devices descending from K981672

113 later devices reach Radiotherapeutics RF-2000 Radiofrequency Generator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023765Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200242—
+1K011676Vivawave Microwave SystemVivant Medical, Inc.2002671
+1K013139Stellartech Coagulation SystemStellartech Research Corp.200142—
+1K994173Stellartech Radiofrequency Generator,Model 1025A-115, Stellartech Radiofrequency…Stellartech Research Corp.200044—
+2K150019TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc.20160—
+2K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated201014—
+2K081042Microthermx-100 Microwave Ablation System and AccessoriesBsd Medical Systems Corp.20082—
+2K072870Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc.200811—
+2K070356Medwaves Microwave Coagulation/Ablation SystemMedwaves Incorporated20072—
+2K070023Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100Microsurgeon, Inc.200741—
+2K061544Stellartech 100 Coagulation SystemStellartech Research Corp.20060—
+2K053535Vivawave Microwave Ablation SystemValleylab200650—
+2K052919Microsulis Tissue Ablation SystemMicrosulis Americas, Inc.200615—
+2K050831Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp.200534—
+2K042909Stellartech Coagulation System, Models 1100C-115A & 1100C-230AStellartech Research Corp.200435—
+2K041383Stellartech Coagulation System, Models 1100C-115 and 1100C-230Stellartech Research Corp.200436—
+2K040240Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200437—
+2K032721Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200338—
+2K032702Vivatip Microwave Ablation ProbeVivant Medical, Inc.200326—
+2K032452Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230Stellartech Research Corp.200339—
+2K032062Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp.200341—
+2K023311Loop Microwave Ablation ProbeVivant Medical, Inc.200328—
+3K183595Aqua Medical RF Vapor SystemAqua Medical, Inc.20194—
+3K181941Swift SystemEmblation, Ltd.20183—
+3K143203AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe…Medwaves Incorporated20150—
+3K141785Micro Thermx Microwave Ablation System and AccessoriesBsd Medical Corp.20150—
+3K141357Barrx Flex Rfa Energy GeneratorCovidien Iic20141—
+3K130623Barrx Channel Rfa Endoscopic CatheterCovidien, LLC20131—
+3K112454HALO60 Ablation CatheterBarrx Medical, Inc.20124—
+3K100744Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc.201039—
+3K100786Microthermx Microwave Ablation System, Models MTX-180 or MTXBsd Medical Corp.20101—
+3K101111Halo Ablation Catheter Model 90-9100, HALO90 Ultra Ablation Catheter Model 90-9200Barrx Medical, Inc.201011
+3K083157HS AmicaH.S Hospital Service S.P.A20094—
+3K082819Dermatologic Treatment System (DTS) G2Miramar Labs, Inc.200910—
+3K082565Microsurgeon Microwave Tissue Ablation Device, Model Mtad-200Microsurgeon, Inc.20090—
+3K083537Modification to Medwaves Microwave Coagulation/Ablation SystemMedwaves Incorporated20091—
+3K082202HALO360 Energy Generator, Models 1100C-115B and 1100C-230BBarrx Medical, Incorporated20080—
+3K062441Barrx Halo Coagulation System; Generator, Model 90-9000; Output Cable, Model 90-9010…Barrx Medical, Incorporated20063—
+3K062225Halo Coagulation CatheterBarrx Medical, Incorporated200620—
+3K060169Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation…Barrx Medical, Incorporated200629—
+3K040279Vivaring Microwave Ablation ProbeVivant Medical, Inc.20043—
+3K032047Tri-Loop Microwave Ablation ProbeVivant Medical, Inc.200327—
+4K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation Limited20250—
+4K251226Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc.20250—
+4K241271Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc.20241—
+4K240480IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation…Varian Medical Systems, Inc.20240—
+4K222388swiftPro SystemEmblation, Ltd.20232—
+4K223272SurBlate Ablation SystemMima-Pro Scientific, Inc.20230—
+4K213627RF Vapor SystemAqua Medical, Inc.20212—
+4K211282Aqua Medical RF Vapor SystemAqua Medical, Inc.20213—
+4K173559Barrx SB RFA Endoscopic CatheterCovidien, LLC20180—
+4K163118FLEX Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20170—
+4K162802Barrx Anorectal RFA WandCovidien, LLC20170—
+4K160936Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc.20165—
+4K160360Barrx FLEX RFA Energy GeneratorCovidien, LLC20160—
+4K150112HS Amica Devices FamilyH.S Hospital Service S.P.A20152—
+4K150251Barrx Anorectal RFA WandCovidien, LLC20151—
+4K130399Certus 140 Certusurggt Surgical ToolNeuwave Medical, Inc.20136—
+4K122217Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc.20128—
+4K120431HALO90 Ultra Ablation CatheterBarrx Medical, Inc.20120—
+4K113237Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc.201238—
+4K103014Miradry SystemMiramar Labs, Inc.201152
+4K092487Haloflex Energy Generator, Models 1190A-115A and 1190A-230ABarrx Medical, Incorporated200921
+4K080557Barrx Models HALO360 and HALO360+ Coagulation CathetersBarrx Medical, Incorporated20080—
+4K071543HALO360' Coagulation CatheterBarrx Medical, Incorporated200719—
+4K062723HALO90 Coagulation CatheterBarrx Medical, Incorporated200626—
+5K240518swiftPro™ SystemEmblation Limited20241—
+5K231738NEUWAVE™ Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20230—
+5K182605HS AMICA devices familyH.S Hospital Service S.P.A20191—
+5K173756Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc.20183—
+5K141511SIDELAZE800 Laser Beam Delivery Accessory for Cynosure 1440MM Wavelength LasersCynosure, Inc.20150—
+5K133821Emprint Ablation SystemCovidien, LLC2014297
+5K131162Miradry SystemMiramar Labs, Inc.201331
+5K093855Halo 360 & Sizing Balloon, Model 3441CBarrx Medical, Incorporated20103—
+5K083737Halo Ablation CatheterBarrx Medical, Incorporated200922—
+5K083711Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20, 32041-22…Barrx Medical, Incorporated200917—
+6K233838Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint…Medtronic, Inc.20240—
+6K232072Amica-Gen Agn-H-1.3, Amica-Gen Agn 3.3, Amica-Probe 17G & 18GH.S Hospital Service S.P.A20240—
+6K200081NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20202—
+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—
+6K171358Emprint SX Ablation Platform and AccessoriesCoviden, LLC20176—
+6K163105Emprint Ablation SystemCovidien, LLC2016133
+6K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc.201661
+6K150419miraDry System MD4000Miramar Labs, Inc.201521
+6K142364Barrx RFA Self Sizing Balloon CatheterCovidien, LLC20140—
+7K220472NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20221—
+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—
+7K200003NP1 Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20201—
+7K200796Emprint Ablation System with Thermosphere TechnologyCovidien, LLC20203—
+7K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc.201844
+7K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc.201751
+7K160141miraDry SystemMiramar Labs, Inc.20161—
+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—