510(k) Report

Devices descending from K950239

1,329 later devices reach Sensimatic 500SE through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050735MC6AMacan Engineering Co.20052—
+1K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.19961,325—
+2K170054iSurgJaco, LLC Dba Macan Manufacturing and Bna Burz North America20170—
+2K052622Macan Model MC-4A Dental Electrosurgical UnitMacan Engineering Co.200501
+2K023672X O Odontosurge 4Xo Care A/S20030—
+2K012631Reprocessed Soft Tissue AblatorsAlliance Medical Corp.20011—
+2K981390Odontosurge 2Periogiene19980—
+2K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.19981,219—
+2K971532Arthrocare Electrosurgery SystemArthrocare Corp.19971,029—
+2K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.19971,322—
+3K062539Ncontact Coagulation System KitNcontact Surgical, Inc.20060—
+3K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical20060—
+3K032838Celon Ent SystemCelon AG Medical Instruments20033—
+3K023765Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200242—
+3K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC200276—
+3K014290Entec Plasma WandsArthrocare Corp.2002119—
+3K011190Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System)Surx, Inc.20023—
+3K013139Stellartech Coagulation SystemStellartech Research Corp.200142—
+3K992180Visage Cosmetic Surgery, Model V5000Arthrocare Corp.20003—
+3K992581Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands, Orthowands…Arthrocare Corp.199923—
+3K992972Arthrocare System 2000 Controller, Arthrocare Cable, Footswitch, Powercord, Arthrocare…Arthrocare Corp.19993—
+3K981870Visage Cosmetic Surgery SystemArthrocare Corp.19981,073—
+3K974521Vnus Closure SystemVnus Medical Technologies, Inc.1998977—
+4K252043Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus…Olympus Winter & Ibe GmbH20250—
+4K191732Sutter RaVoR Bipolar ElectrodesSutter Medizintechnik GmbH20190—
+4K152703PlasmaBlade TnA Tonsil and Adenoid Dissection DeviceMedtronic Advanced Energy20160—
+4K160639Electrosurgical Generator ESG-200Olympus Winter & Ibe GmbH20160—
+4K150297PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy20150—
+4K123353Ciq Controller, Ciq WandsArthroCare Corporation20130—
+4K091310Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682Dfine, Inc.201011—
+4K100543Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss201001
+4K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated201014—
+4K072261Finesse SystemPrimaeva Medical, Inc.2007100—
+4K072126Habib VesealEmcision, Ltd.20070—
+4K070374Arthrocare Ent Plasma WandArthrocare Corp.2007391
+4K061544Stellartech 100 Coagulation SystemStellartech Research Corp.20060—
+4K050831Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp.200534—
+4K042909Stellartech Coagulation System, Models 1100C-115A & 1100C-230AStellartech Research Corp.200435—
+4K041633Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc.20048—
+4K041285Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision…Gyrus Medical, Ltd.2004202
+4K041383Stellartech Coagulation System, Models 1100C-115 and 1100C-230Stellartech Research Corp.200436—
+4K040240Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200437—
+4K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC200450—
+4K033547Vnus Vessel and Tissue Coagulation SystemVnus Medical Technologies, Inc.20046—
+4K032721Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200338—
+4K032452Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230Stellartech Research Corp.200339—
+4K032062Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp.200341—
+4K023111Gyrus Plasma Skin Resurfacing SystemGyrus Medical, Inc.20030—
+4K023624SLT Venous Fiber Delivery Systems, Model…Surgical Laser Technologies, Inc.20032—
+4K020952Surx RF SystemSurx, Inc.20021—
+4K021364Modification to Entec Plasma WandsArthrocare Corp.200294—
+4K014251Ntero Hotrod SystemNtero Surgical, Inc.20020—
+4K020126Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories…Surx, Inc.20022—
+4K012398Diomed 15 Diode LaserDiomed, Ltd.2002714—
+4K012679Reprocessed RF Arthroscopy ProbesSterilmed, Inc.200101
+4K012129Ortho Development Orion-I Emf SystemOrtho Development Corp.20010—
+4K000944Thermage Thermacool SystemThermage, Inc.20001,069—
+4K982816Vnus Closure SystemVnus Medical Technologies, Inc.1999973—
+5K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+5K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter…ArthroCare Corporation20202—
+5K192027WEREWOLF COBLATION System, COBLATION HALO WandArthroCare Corporation20193—
+5K183595Aqua Medical RF Vapor SystemAqua Medical, Inc.20194—
+5K172647Reprocessed ArthroCare ENT CoblatorRenovo, Inc.20180—
+5K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+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
+5K141357Barrx Flex Rfa Energy GeneratorCovidien Iic20141—
+5K130689Symphony RF GeneratorThermigen, Inc.201311—
+5K130623Barrx Channel Rfa Endoscopic CatheterCovidien, LLC20131—
+5K122652Arthrocare Turbinator WandArthroCare Corporation20133—
+5K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+5K121678DTADGyrus Acmi, Inc.20122—
+5K111523Osteocool (TM) RF Ablation SystemBaylis Medical Co., Inc.20120—
+5K112454HALO60 Ablation CatheterBarrx Medical, Inc.20124—
+5K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+5K101111Halo Ablation Catheter Model 90-9100, HALO90 Ultra Ablation Catheter Model 90-9200Barrx Medical, Inc.201011
+5K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+5K082391Primaeva Medical Renesis SystemPrimaeva Medical, Inc.200959—
+5K080844G3 Generator and Accessories-Dissector Plasma KnifeGyrus Acmi, Inc.20091—
+5K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.20098—
+5K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080—
+5K082962Tivamed Cooled RF System, Model 78001Tivamed, Inc.20087—
+5K082202HALO360 Energy Generator, Models 1100C-115B and 1100C-230BBarrx Medical, Incorporated20080—
+5K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc.20081—
+5K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+5K080145Primaeva Medical SystemPrimaeva Medical, Inc.200899—
+5K070353Kelsey Intersitital Laser Therapy SystemKelsey, Inc.20071—
+5K062441Barrx Halo Coagulation System; Generator, Model 90-9000; Output Cable, Model 90-9010…Barrx Medical, Incorporated20063—
+5K062225Halo Coagulation CatheterBarrx Medical, Incorporated200620—
+5K060169Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation…Barrx Medical, Incorporated200629—
+5K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.200514—
+5K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc.20056—
+5K052003Vnus RFS, Model RFS-6-XX (XX = 10, 12, 13, & 15); Vnus RFS Flex, Model RFX-6-XX (XX =…Vnus Medical Technologies, Inc.20055—
+5K051996Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd.200589—
+5K043402Thermage Thermacool SystemThermage, Inc.2005124—
+5K042132Novasys Transurethral RF SystemNovasys Medical, Inc.200401
+5K041957Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc.20042971
+5K040921Cooltouch, Model NS 160Cooltouch, Inc.2004204—
+5K040638Vnus Radiofrequency Generator, Model RFG2Vnus Medical Technologies, Inc.200410—