510(k) Report

Devices descending from K952681

1,700 later devices reach Stryker Hummer II Microdebrider System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990038Hummer Trak SystemStryker Endoscopy19990—
+1K981637Integrated Drive/Pump System for OtolaryngologyLinvatec Corp.1998478—
+1K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.19981,219—
+2K032838Celon Ent SystemCelon AG Medical Instruments20033—
+2K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC200276—
+2K014290Entec Plasma WandsArthrocare Corp.2002119—
+2K012631Reprocessed Soft Tissue AblatorsAlliance Medical Corp.20011—
+2K992581Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands, Orthowands…Arthrocare Corp.199923—
+2K990524E9000 SystemLinvatec Corp.1999477—
+2K981870Visage Cosmetic Surgery SystemArthrocare Corp.19981,073—
+3K252043Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus…Olympus Winter & Ibe GmbH20250—
+3K191732Sutter RaVoR Bipolar ElectrodesSutter Medizintechnik GmbH20190—
+3K152703PlasmaBlade TnA Tonsil and Adenoid Dissection DeviceMedtronic Advanced Energy20160—
+3K160639Electrosurgical Generator ESG-200Olympus Winter & Ibe GmbH20160—
+3K150297PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy20150—
+3K123353Ciq Controller, Ciq WandsArthroCare Corporation20130—
+3K092977Eberle Shaver System AccessoriesEfs Eberle Feinwerktechnische Systeme20101—
+3K091310Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682Dfine, Inc.201011—
+3K100543Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss201001
+3K083284Piezosurgery MedicalPiezosurgery S.R.L.20099—
+3K083161Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100)Conmed Linvatec20099—
+3K072261Finesse SystemPrimaeva Medical, Inc.2007100—
+3K070374Arthrocare Ent Plasma WandArthrocare Corp.2007391
+3K061134Eberle Shaver System C2 and Shaver BladesEfs Eberle Feinwerktechnische Systeme20062—
+3K060172Rema Shaver BladesRema Medizintechnik GmbH.20060—
+3K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical20060—
+3K052695Suretek Medical Reprocessed Arthroscopic Blades and BursSuretek Medical20060—
+3K041633Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc.20048—
+3K041285Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision…Gyrus Medical, Ltd.2004202
+3K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC200450—
+3K033547Vnus Vessel and Tissue Coagulation SystemVnus Medical Technologies, Inc.20046—
+3K021364Modification to Entec Plasma WandsArthrocare Corp.200294—
+3K012630Reprocessed Linvatec Arthroscopic BursAlliance Medical, Inc.20010—
+3K012679Reprocessed RF Arthroscopy ProbesSterilmed, Inc.200101
+3K012613Reprocssed Linvatec ShaversAlliance Medical, Inc.200101
+3K012453Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery)Sodemsystems2001447—
+3K012457Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems2001447—
+3K012456Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems2001446—
+3K012129Ortho Development Orion-I Emf SystemOrtho Development Corp.20010—
+3K000944Thermage Thermacool SystemThermage, Inc.20001,069—
+3K992180Visage Cosmetic Surgery, Model V5000Arthrocare Corp.20003—
+4K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+4K193608EBERLE Shaver System C3 and AccessoriesEberle GmbH & Co. KG20210—
+4K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter…ArthroCare Corporation20202—
+4K192027WEREWOLF COBLATION System, COBLATION HALO WandArthroCare Corporation20193—
+4K172647Reprocessed ArthroCare ENT CoblatorRenovo, Inc.20180—
+4K170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw…Medtronic Powered Surgical Solutions201711—
+4K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+4K142480OsteoCool V-2 RF Ablation SystemBaylis Medical Company, Inc.20159—
+4K142289PK SpatulaGyrus Acmi, Inc.20141—
+4K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated…ArthroCare Corporation201443
+4K132848Piezosurgery FlexMectron S.P.A.20136—
+4K130689Symphony RF GeneratorThermigen, Inc.201311—
+4K122652Arthrocare Turbinator WandArthroCare Corporation20133—
+4K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+4K121678DTADGyrus Acmi, Inc.20122—
+4K111523Osteocool (TM) RF Ablation SystemBaylis Medical Co., Inc.20120—
+4K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+4K100638Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214Depuy Mitek, A Johnson & Johnson Company20108—
+4K100410Piezoelectric SystemSatelec20108—
+4K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+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—
+4K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080—
+4K082962Tivamed Cooled RF System, Model 78001Tivamed, Inc.20087—
+4K081475Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc.20084433
+4K081277XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc)Medtronic Xomed, Inc.20084201
+4K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc.20081—
+4K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+4K080145Primaeva Medical SystemPrimaeva Medical, Inc.200899—
+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
+4K022986The Bioplate Battery Powered DrillBioplate, Inc.20020—
+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—
+5K254174Surgical Power SystemGuizhou Zirui Technology Co., Ltd.20260—
+5K253680LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation20260—
+5K251996ENTire IRE SystemEntire Medical, Ltd.20261—
+5K233958hekaDrillZethon, Ltd.20240—
+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—
+5K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF…Venclose, Inc.202121
+5K193630hekaDrillZethon, Ltd.20210—
+5K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+5K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions20194—
+5K181044400um Perforator and Accessory Vein Ablation KitAngioDynamics, Inc.20180—
+5K172464XD880A Ultrasonic Osteotomy Surgical SystemMorley Research Consortium20182—
+5K173214NES Reprocessed RF Stylet (RFS)Northeast Scientific, Inc. (Nes)20180—
+5K173740Reprocessed DePuy Mitek Ablation WandRenovo, Inc.20180—
+5K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—