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
+6K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+6K183644Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions20193—
+6K180359BTL-FR2000BTL Industries, Inc.20189—
+6K180945LUTRONIC GENIUS Radiofrequency SystemLutronic Corporation20181—
+6K180872Scarlet SRFVIOL Co., Ltd.20184—
+6K182436POWEREASE SystemMedtronic Sofamor Danek USA, Inc.20180—
+6K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+6K180584Viveve RF System, SecureViveve, Inc.20185—
+6K173759Thermage CPT System and AccessoriesSolta Medical201821
+6K172023CelfirmVIOL Co., Ltd.20173—
+6K170758Thermage FLX System and AccessoriesSolta Medical201713—
+6K170908PK AIMGyrus Acmi, Inc.20170—
+6K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+6K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions201701
+6K170116Thermi Injectable RF ElectrodesThermi20172—
+6K161949OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc.20177—
+6K162851eLyx-PROIntelligent Sensory Concept SA20170—
+6K163190InMode RF SystemInmode MD, Ltd.20160—
+6K160312Fraxis DuoIlooda Co,., Ltd.201614—
+6K161825PK AIMGyrus Acmi, Inc.20162—
+6K160554Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20166—
+6K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+6K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm…Bovie Medical Corporation201623
+6K153727INTRAcel Premium Fractional RF Micro Needle (FRM) SystemJeisys Medical, Inc.201627—
+6K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC20164—
+6K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+6K150409VIVACE Electrosurgical SystemSung Hwan E&B Co.,Ltd201681
+6K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+6K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+6K150524Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings, Inc.20150—
+6K151340HARMONIC Focus Long Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20150—
+6K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+6K150336Photonica ProfessionalWard Photonics, LLC20157—
+6K142759PK Cutting Forceps for ESG-400 WorkstationGyrus Acmi, Inc.20152—
+6K133405MinnieElettronica Valseriana Srl20140—
+6K140454Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc.20143961
+6K134017GigalaserPowermedic Aps20141—
+6K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+6K132431Thermage CPT SystemSolta Medical, Inc.2013171
+6K122966XP200Btl Industries, Ltd.20131—
+6K124004Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc.20134041
+6K130283Evrf SystemF Care Systems NV20132—
+6K123270Powerease SystemMedtronic Sofamor Danek USA, Inc.2013398—
+6K120460SmartluxMedmix Co., Ltd.201218—
+6K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+6K120527Alpha Orthopaedics AT2 SystemAlpha Orthopaedics, Inc.20120—
+6K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+6K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+6K112334Vein-Gogh InstrumentRefine USA, LLC20120—
+6K101916Joule Multi-Platform SystemSciton, Inc2011111—
+6K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+6K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+6K102003Xpress Balloon DeviceEntellus Medical, Inc.201036—
+6K092734E-Light LineEspansione Marketing S.P.A20102—
+6K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+6K093007Entellus Medical Balloon DeviceEntellus Medical, Inc.201041—
+6K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+6K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+6K090762LEDAQuantel Derma GmbH200946—
+6K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+6K082834Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc.2009561
+6K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+6K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+6K082247Evis MD Platinum Red Light TherapyAgeless Beauty Corporation20081—
+6K073000LumaprobeClareblend, Inc.20080—
+6K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+6K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+6K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+6K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+6K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+6K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+6K071786Portrait PSRRhytec Incorporated2007109—
+6K070388Profile Multi-Platform SystemSciton, Inc2007129—
+6K060792IllumimedPhotoactif, LLC2006115—
+6K063538Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot Control…Arthrocare Corp.200640—
+6K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+6K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+6K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+6K052778Thermage Thermacool Skin MarketingThermage, Inc.2005130—
+6K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+6K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+6K051255Lumiphase-ROpusmed, Inc.2005143—
+6K050397Velasmooth, ShaperSyneron Medical, Ltd.2005150—
+6K050452Aurora SR and Sra ApplicatorSyneron Medical, Ltd.2005301—
+6K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+6K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+6K032514AC Applicator, Aurora ACSyneron Medical, Ltd.20041—
+6K033586Modification to Aurora DSSyneron Medical, Ltd.2003303—
+6K031671Polaris WRSyneron Medical, Ltd.2003678—
+6K030186Polris LVSyneron Medical, Ltd.2003680—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+7K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+7K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+7K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+7K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—