510(k) Report

Devices descending from K921884

1,365 later devices reach FORCE 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K130623Barrx Channel Rfa Endoscopic CatheterCovidien, LLC20131—
+4K122652Arthrocare Turbinator WandArthroCare Corporation20133—
+4K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+4K130521Isolator Linear PenAtriCure, Inc.20133—
+4K123733Cardioblate Cryoflex Surgical Ablation SystemMedtronic, Inc.201315
+4K121678DTADGyrus Acmi, Inc.20122—
+4K121451Cardioblate Maps Surgical Mapping, Ablation, Pacing , and Sensing DeviceMedtronic, Inc.20120—
+4K113475Estech Cobra Adhere XL 2 Surgical SystemEndoscopic Technologies, Inc. D/B/A Estech201245
+4K111523Osteocool (TM) RF Ablation SystemBaylis Medical Co., Inc.20120—
+4K112454HALO60 Ablation CatheterBarrx Medical, Inc.20124—
+4K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+4K111042Atricure Cryo ModuleAtriCure, Inc.201114—
+4K101111Halo Ablation Catheter Model 90-9100, HALO90 Ultra Ablation Catheter Model 90-9200Barrx Medical, Inc.201011
+4K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+4K092487Haloflex Energy Generator, Models 1190A-115A and 1190A-230ABarrx Medical, Incorporated200921
+4K082391Primaeva Medical Renesis SystemPrimaeva Medical, Inc.200959—
+4K080844G3 Generator and Accessories-Dissector Plasma KnifeGyrus Acmi, Inc.20091—
+4K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.20098—
+4K090202Numeris Guided Coagulation System with Visitrax, Models CSK-121, -122, -123 and -125Ncontact Surgical, Inc.20093—
+4K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080—
+4K082962Tivamed Cooled RF System, Model 78001Tivamed, Inc.20087—
+4K082279Epicor Ablation Control System, Model Acs-US-2, Acs-Eur-2St Jude Medical20080—
+4K080287Oncobionic Bipolar ElectrodeAngioDynamics, Inc.20080—
+4K080202Oncobionic System with 6 Probe OutputOncobionics, Inc.2008111
+4K081082U-Clip Uni-Fire, Model M65Medtronic, Inc.20080—
+4K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc.20081—
+4K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+4K080376Oncobionic SystemOncobionic Incorporated2008111
+4K080557Barrx Models HALO360 and HALO360+ Coagulation CathetersBarrx Medical, Incorporated20080—
+4K080145Primaeva Medical SystemPrimaeva Medical, Inc.200899—
+4K071543HALO360' Coagulation CatheterBarrx Medical, Incorporated200719—
+4K070311Cardioblate Gemini Surgical Ablation Device, Models 49260 and 49261Medtronic Vascular20071—
+4K063630Atricure Ablation SystemAtriCure, Inc.20077—
+4K060346Ultrazonix Spine Minimal-Invasive Disc SystemUltrazonix Dnt AB20060—
+4K062723HALO90 Coagulation CatheterBarrx Medical, Incorporated200626—
+4K062057U-Clip Device, Model NC65Medtronic Vascular20062—
+4K053100Estech Cobra Bipolar SystemEndoscopic Technologies, Inc.20052—
+4K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.200514—
+4K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc.20056—
+4K052003Vnus RFS, Model RFS-6-XX (XX = 10, 12, 13, & 15); Vnus RFS Flex, Model RFX-6-XX (XX =…Vnus Medical Technologies, Inc.20055—
+4K043402Thermage Thermacool SystemThermage, Inc.2005124—
+4K033942Thermage Thermacool SystemThermage, Inc.2004527—
+4K030033Lumenis Family of Disposable Contact Tip Delivery DevicesLumenis, Ltd.20030—
+4K023111Gyrus Plasma Skin Resurfacing SystemGyrus Medical, Inc.20030—
+4K030108Arthrocare Ent Coblator Surgery SystemArthrocare Corp.2003921
+4K021402Thermage Thermacool TC SystemThermage, Inc.2002789—
+4K022266Aurora SRSyneron Medical, Ltd.2002705—
+4K021149Aurora DSSyneron Medical, Ltd.2002750—
+4K013639Thermage Thermacool TC SystemThermage, Inc.2002799—
+4K013034Modification to: Thermacool IiaThermage, Inc.2001800—
+5K253680LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation20260—
+5K251996ENTire IRE SystemEntire Medical, Ltd.20261—
+5K251226Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc.20250—
+5K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc.20250—
+5K241271Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc.20241—
+5K243157AtriCure cryoICE BOX (ACM)AtriCure, Inc.20240—
+5K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc.20240—
+5K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC20240—
+5K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System…ArthroCare Corporation20230—
+5K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc.20220—
+5K213627RF Vapor SystemAqua Medical, Inc.20212—
+5K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF…Venclose, Inc.202121
+5K211282Aqua Medical RF Vapor SystemAqua Medical, Inc.20213—
+5K191526Cardioblate CryoFlex Surgical Ablation SystemMedtronic, Inc.20190—
+5K190587Coolrail Linear PenAtriCure, Inc.20191—
+5K190151COBRA Fusion Ablation SystemAtriCure, Inc.20190—
+5K181044400um Perforator and Accessory Vein Ablation KitAngioDynamics, Inc.20180—
+5K173214NES Reprocessed RF Stylet (RFS)Northeast Scientific, Inc. (Nes)20180—
+5K180138AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc.20184—
+5K180137AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation…AtriCure, Inc.20180—
+5K173559Barrx SB RFA Endoscopic CatheterCovidien, LLC20180—
+5K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+5K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+5K162802Barrx Anorectal RFA WandCovidien, LLC20170—
+5K163408Isolator Multifunctional Linear PenAtriCure, Inc.20172—
+5K161038PK MorcellatorGyrus Acmi, Inc.20160—
+5K162547Viveve SystemViveve, Inc.20166—
+5K161043Profound SystemSyneron Candela Corporation20160—
+5K161661Thermi RF AccessoriesThermi20163—
+5K160360Barrx FLEX RFA Energy GeneratorCovidien, LLC20160—
+5K152337cryoFORM cryoICE cryoablation probeAtriCure, Inc.20162—
+5K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+5K151793InMode RF SystemInmode MD, Ltd.20161—
+5K152702Ent Biotech Solutions Tissue Removal Device (Elasso)Ent Biotech Solutions20160—
+5K152057OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc.20158—
+5K150251Barrx Anorectal RFA WandCovidien, LLC20151—
+5K142350PK J-HookGyrus Acmi, Inc.201511
+5K142525PK Lap LoopOlympus Winter & Ibe GmbH20140—
+5K130501IntensifEndymed Medical, Ltd.201457—
+5K140058Atricure Cryo Module SystemAtriCure, Inc.2014102
+5K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+5K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+5K131205Arthrocare Head and Neck Coblation WandArthroCare Corporation20130—
+5K130305Lina Bipolar Loop; Standard Size, Large Size, Extra Large SizeLina Medical Aps20130—
+5K121481Infini Radiofrequency SystemLutronic Corporation201357—
+5K122605PKS BillGyrus Acmi, Inc.20121—
+5K120857Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.20122—
+5K120431HALO90 Ultra Ablation CatheterBarrx Medical, Inc.20120—
+5K102329Nanoknife SystemAngioDynamics, Inc.2011101
+5K112072Atricure Cryo Module SystemAtriCure, Inc.201113—