510(k) Report

Devices descending from K921884

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K103775Peak Suction CoagulatorPeak Surgical, Inc.20111—
+5K102366Finess EndoscopeEntellus Medical, Inc.20110—
+5K102709Peak Plasmablade Plus Tissue Dissection DevicePeak Surgical, Inc.20100—
+5K100896Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc.201031
+5K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+5K100224Estech Cobra Bipolsr IIEndoscopic Technologies, Inc. D/B/A Estech20101—
+5K091674Arthrocare Coblator IQ SystemArthrocare Corp.20101—
+5K093855Halo 360 & Sizing Balloon, Model 3441CBarrx Medical, Incorporated20103—
+5K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+5K090869Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula…Medtronic Perfusion Systems20090—
+5K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+5K083352Veinwave, TC3000Newlands Clinical Trials, Ltd.20094—
+5K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+5K083737Halo Ablation CatheterBarrx Medical, Incorporated200922—
+5K083711Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20, 32041-22…Barrx Medical, Incorporated200917—
+5K082956Alpha Orthopaedics AT2 SystemAlpha Orthopaedics20081—
+5K081766PKS Omni InstrumentGyrus-Acmi L.P.200831
+5K081954Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector CableGyrus Acmi, Inc.20080—
+5K071759LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand…Live Tissue Connect, Inc.20080—
+5K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc.200842—
+5K072849Modification to Thermage Thermacool SystemThermage, Inc.200820—
+5K052936Thermage Thermacool SystemThermage, Inc.2007103—
+5K070004AccentAlma Lasers, Ltd.2007181—
+5K062821U-Clip DeviceMedtronic Neurosurgery20060—
+5K060948Portrait PSR3Rhytec Incorporated20061101
+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—
+5K033257Arthrocare Ent Plasma WandsArthrocare Corp.200342—
+5K031489PitangaSyneron Medical, Ltd.20030—
+5K032088Modification to Thermacool TC SystemThermage, Inc.2003131—
+5K031988Aurora DSSyneron Medical, Ltd.2003450—
+5K031993Aurora SRSyneron Medical, Ltd.2003303—
+5K030426Omnilux RedPhoto Therapeutics Limited2003563—
+5K031046Thermacool TC SystemThermage, Inc.200322—
+5K024064Polaris DSSyneron Medical, Ltd.2003681—
+5K030142Thermacool TC SystemThermage, Inc.2003773—
+6K261202ENTire IRE SystemEntire Medical, Ltd.20260—
+6K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console…Medinice S.A.20260—
+6K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+6K250068Venclose digiRF Generator (VCRFG1)Venclose, Inc.202511
+6K240376Electroporation System (N3000)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.20240—
+6K240070Profound MatrixCandela Corporation20240—
+6K231749Radio Frequency SystemShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+6K222556BTL-785XBTL Industries, Inc.20235—
+6K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+6K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+6K211639BTL-785WBTL Industries, Inc.20227—
+6K210077MED RF 4000F Care Systems USA, LLC20211—
+6K211217Profound MatrixCandela Corporation20210—
+6K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+6K200697AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation…AtriCure, Inc.20202—
+6K192621Medical RFTriworks Group Srl20200—
+6K193201BTL-785FBtl20208—
+6K200104OxylightRaja Trading Company, Inc.202024—
+6K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+6K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+6K180359BTL-FR2000BTL Industries, Inc.20189—
+6K180945LUTRONIC GENIUS Radiofrequency SystemLutronic Corporation20181—
+6K182565AtriCure cryoICE cryoSPHERE cryoablation probeAtriCure, Inc.20183—
+6K180872Scarlet SRFVIOL Co., Ltd.20184—
+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—
+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—
+6K153727INTRAcel Premium Fractional RF Micro Needle (FRM) SystemJeisys Medical, Inc.201627—
+6K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc.201661
+6K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC20164—
+6K150409VIVACE Electrosurgical SystemSung Hwan E&B Co.,Ltd201681
+6K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+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—
+6K150089NanoKnife SystemAngioDynamics, Inc.201581
+6K150336Photonica ProfessionalWard Photonics, LLC20157—
+6K142759PK Cutting Forceps for ESG-400 WorkstationGyrus Acmi, Inc.20152—
+6K142084Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.201411
+6K142364Barrx RFA Self Sizing Balloon CatheterCovidien, LLC20140—
+6K133405MinnieElettronica Valseriana Srl20140—
+6K134017GigalaserPowermedic Aps20141—
+6K133672Reprocessed Harmonic Ace Shears Without Adaptive Tissue TechnologyStryker Sustainability Solutions20140—
+6K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+6K133017Estech Cobra (R) Genesis Bipolar ClampEstech, Inc.20130—
+6K132431Thermage CPT SystemSolta Medical, Inc.2013171
+6K122966XP200Btl Industries, Ltd.20131—
+6K130283Evrf SystemF Care Systems NV20132—
+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—