510(k) Report

Devices descending from K955531

1,329 later devices reach Arthrocare Bipolar Loop Electrode System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K173214NES Reprocessed RF Stylet (RFS)Northeast Scientific, Inc. (Nes)20180—
+5K172647Reprocessed ArthroCare ENT CoblatorRenovo, 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—
+5K162547Viveve SystemViveve, Inc.20166—
+5K161043Profound SystemSyneron Candela Corporation20160—
+5K160754Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)Venclose, Inc.201632
+5K161661Thermi RF AccessoriesThermi20163—
+5K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+5K160360Barrx FLEX RFA Energy GeneratorCovidien, LLC20160—
+5K160392Novilase Laser Therapy System, Model LTS-2Novian Health, Inc.20160—
+5K151793InMode RF SystemInmode MD, Ltd.20161—
+5K150251Barrx Anorectal RFA WandCovidien, LLC20151—
+5K142480OsteoCool V-2 RF Ablation SystemBaylis Medical Company, Inc.20159—
+5K142289PK SpatulaGyrus Acmi, Inc.20141—
+5K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated…ArthroCare Corporation201443
+5K141858Closurerfg Radiofrequency GeneratorCovidien20142—
+5K130501IntensifEndymed Medical, Ltd.201457—
+5K122652Arthrocare Turbinator WandArthroCare Corporation20133—
+5K121481Infini Radiofrequency SystemLutronic Corporation201357—
+5K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+5K121678DTADGyrus Acmi, Inc.20122—
+5K120431HALO90 Ultra Ablation CatheterBarrx Medical, Inc.20120—
+5K111523Osteocool (TM) RF Ablation SystemBaylis Medical Co., Inc.20120—
+5K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+5K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+5K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+5K093502Vari-Lase Endovenous Laser ConsoleVascular Solutions, Inc.20100—
+5K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+5K092487Haloflex Energy Generator, Models 1190A-115A and 1190A-230ABarrx Medical, Incorporated200921
+5K080844G3 Generator and Accessories-Dissector Plasma KnifeGyrus Acmi, Inc.20091—
+5K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+5K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+5K083352Veinwave, TC3000Newlands Clinical Trials, Ltd.20094—
+5K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.20098—
+5K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+5K082956Alpha Orthopaedics AT2 SystemAlpha Orthopaedics20081—
+5K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080—
+5K073427Medilas D Family LasersDornier Medtech America, Inc.200881—
+5K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+5K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc.20081—
+5K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+5K080557Barrx Models HALO360 and HALO360+ Coagulation CathetersBarrx Medical, Incorporated20080—
+5K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+5K073464Angiodynamics, Inc., Nevertouch II 400UM Fiber and Venacure Procedure KitAngioDynamics, Inc.20080—
+5K072849Modification to Thermage Thermacool SystemThermage, Inc.200820—
+5K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+5K071543HALO360' Coagulation CatheterBarrx Medical, Incorporated200719—
+5K052936Thermage Thermacool SystemThermage, Inc.2007103—
+5K070536Medilas D Family LasersDornier Medtech America, Inc.2007197—
+5K070004AccentAlma Lasers, Ltd.2007181—
+5K063828Diomed Delta 25Diomed, Ltd.20075—
+5K062822Vari-Lase Endovenous Laser Console, Model 7500Vascular Solutions, Inc.2006132—
+5K062723HALO90 Coagulation CatheterBarrx Medical, Incorporated200626—
+5K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+5K060948Portrait PSR3Rhytec Incorporated20061101
+5K061373Vnus Closurefast Catheter, Models CF7-7-60 and CF7-7-100Vnus Medical Technologies, Inc.2006132
+5K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.200514—
+5K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc.20056—
+5K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+5K051710Thermage Thermacool Coupling FluidThermage, Inc.200556—
+5K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+5K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+5K040135Thermage Thermacool SystemThermage, Inc.2004496—
+5K032805Modification to Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc.20030—
+5K031489PitangaSyneron Medical, Ltd.20030—
+5K032088Modification to Thermacool TC SystemThermage, Inc.2003131—
+5K031988Aurora DSSyneron Medical, Ltd.2003450—
+5K031993Aurora SRSyneron Medical, Ltd.2003303—
+5K030033Lumenis Family of Disposable Contact Tip Delivery DevicesLumenis, Ltd.20030—
+5K030426Omnilux RedPhoto Therapeutics Limited2003563—
+5K031046Thermacool TC SystemThermage, Inc.200322—
+5K030186Polris LVSyneron Medical, Ltd.2003680—
+5K024064Polaris DSSyneron Medical, Ltd.2003681—
+5K030142Thermacool TC SystemThermage, Inc.2003773—
+5K030108Arthrocare Ent Coblator Surgery SystemArthrocare Corp.2003921
+6K253918Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)F Care Systems USA, LLC20260—
+6K253680LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation20260—
+6K251996ENTire IRE SystemEntire Medical, Ltd.20261—
+6K250688Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency…Acotec Scientific Co., Ltd.20250—
+6K252316Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)Venclose, Inc.20250—
+6K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+6K250068Venclose digiRF Generator (VCRFG1)Venclose, Inc.202511
+6K240070Profound MatrixCandela Corporation20240—
+6K231749Radio Frequency SystemShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+6K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System…ArthroCare Corporation20230—
+6K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+6K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+6K222556BTL-785XBTL Industries, Inc.20235—
+6K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+6K223488ClosureFast™ Endovenous Radiofrequency Ablation CatheterMedtronic, Inc.20230—
+6K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+6K211639BTL-785WBTL Industries, Inc.20227—
+6K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc.20220—
+6K210077MED RF 4000F Care Systems USA, LLC20211—
+6K211217Profound MatrixCandela Corporation20210—
+6K202288FinebeamSNJ Co., Ltd.20212—
+6K192621Medical RFTriworks Group Srl20200—