510(k) Report

Devices descending from K962313

68 later devices reach Modified Leveen Needle Electrode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K011676Vivawave Microwave SystemVivant Medical, Inc.2002671
+2K150019TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc.20160—
+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—
+2K053535Vivawave Microwave Ablation SystemValleylab200650—
+2K052919Microsulis Tissue Ablation SystemMicrosulis Americas, Inc.200615—
+2K032702Vivatip Microwave Ablation ProbeVivant Medical, Inc.200326—
+2K023311Loop Microwave Ablation ProbeVivant Medical, Inc.200328—
+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—
+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—
+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—
+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—
+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—
+4K163118FLEX Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20170—
+4K160936Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc.20165—
+4K150112HS Amica Devices FamilyH.S Hospital Service S.P.A20152—
+4K130399Certus 140 Certusurggt Surgical ToolNeuwave Medical, Inc.20136—
+4K122217Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc.20128—
+4K113237Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc.201238—
+4K103014Miradry SystemMiramar Labs, Inc.201152
+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
+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
+6K150419miraDry System MD4000Miramar Labs, Inc.201521
+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—
+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—
+8K233140Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)Hygea Medical Technology Co., Ltd.20240—
+8K232240Microwave Ablation System (BD-GT)Betters (Suzhou) Medical Co., Ltd.20231—
+8K232241Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818…Betters (Suzhou) Medical Co., Ltd.20231—
+8K223138AB1 Electrosurgical Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20231—
+8K221672Creo Electrosurgical System with NP1 InstrumentCreo Medical, Ltd.20230—
+8K180396miraDry SystemMiramar Labs, Inc.20180—
+9K252632Microwave Ablation DeviceNanjing Dewen Medical Technology Co., Ltd.20260—
+9K253771Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14…Nanjing Devin Medical Technology Co., Ltd.20260—
+9K242983CROMA Electrosurgical Generator (PRD-EMR-050)Creo Medical, Ltd.20250—