510(k) Report

Devices descending from K001253

220 later devices reach Surgitron Iec II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030473Senorx ES-300Senorx, Inc.20030—
+1K014290Entec Plasma WandsArthrocare Corp.2002119—
+1K013255Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc.2001104—
+1K012799ES-2000 Shape Select Electrosurgical ScalpelSenorx, Inc.20012—
+2K200931RF Surgical GeneratorFulwell, LLC20200—
+2K152703PlasmaBlade TnA Tonsil and Adenoid Dissection DeviceMedtronic Advanced Energy20160—
+2K150297PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy20150—
+2K123366Surgitron 4.0 Dual RF S5-IecEllman International, Inc.2013161
+2K123353Ciq Controller, Ciq WandsArthroCare Corporation20130—
+2K100543Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss201001
+2K082834Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc.2009561
+2K073057Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection Device, Model…Peak Surgical, Inc.200833—
+2K070374Arthrocare Ent Plasma WandArthrocare Corp.2007391
+2K070275Flexible Loop Electrosurgical ElectrodeRubicor Medical, Inc.20070—
+2K061174Surgi-MaxEllman Int'L, Inc.200635—
+2K051956DR. Oppel ST-501Sometech Incorporated20051—
+2K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC200276—
+2K021707Single Step Biopsy Device, Single Step Surgical Handle, Single Step Driver, Single Step…Senorx, Inc.20020—
+2K021364Modification to Entec Plasma WandsArthrocare Corp.200294—
+3K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter…ArthroCare Corporation20202—
+3K192027WEREWOLF COBLATION System, COBLATION HALO WandArthroCare Corporation20193—
+3K182365TempSure SystemCynosure, Inc.201815—
+3K181257PlasmaBlade X 3.0S, PlasmaBlade X 4.0Medtronic Advanced Energy20183—
+3K172647Reprocessed ArthroCare ENT CoblatorRenovo, Inc.20180—
+3K134036Wavetronic 5000 Digital HF Surgical UnitLoktal Medical Electronics Ind. Com. Ltda- Epp20150—
+3K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated…ArthroCare Corporation201443
+3K130689Symphony RF GeneratorThermigen, Inc.201311—
+3K122652Arthrocare Turbinator WandArthroCare Corporation20133—
+3K122966XP200Btl Industries, Ltd.20131—
+3K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+3K100390Surgimax/ Surgimax PlusElliquence, LLC201010—
+3K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+3K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+3K083352Veinwave, TC3000Newlands Clinical Trials, Ltd.20094—
+3K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.20098—
+3K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection DevicesPeak Surgical, Inc.2008241
+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—
+3K030033Lumenis Family of Disposable Contact Tip Delivery DevicesLumenis, Ltd.20030—
+3K030108Arthrocare Ent Coblator Surgery SystemArthrocare Corp.2003921
+4K253680LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation20260—
+4K251996ENTire IRE SystemEntire Medical, Ltd.20261—
+4K240311JETT Medical IICompex, Spol, S.R.O.20250—
+4K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System…ArthroCare Corporation20230—
+4K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+4K210077MED RF 4000F Care Systems USA, LLC20211—
+4K193579PlasmaBlade X 3.0S LIGHTMedtronic Navigation20202—
+4K190678TempSureCynosure, Inc.201914—
+4K171869Sutter CURIS RF GeneratorSutter Medizintechnik GmbH20181—
+4K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+4K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+4K170107Surgi Max UltraElliquence, LLC20177—
+4K161661Thermi RF AccessoriesThermi20163—
+4K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+4K160041Cobbra RF Tissue DissectorElliquence, LLC20166—
+4K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+4K151793InMode RF SystemInmode MD, Ltd.20161—
+4K152702Ent Biotech Solutions Tissue Removal Device (Elasso)Ent Biotech Solutions20160—
+4K142410Elliquence ElectrodesElliquence, LLC20157—
+4K143109XP300BTL Industries, Inc.20150—
+4K142289PK SpatulaGyrus Acmi, Inc.20141—
+4K143175AEx Generator; PlasmaBlade TMedtronic Advanced Energy20141—
+4K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+4K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+4K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+4K132431Thermage CPT SystemSolta Medical, Inc.2013171
+4K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+4K130283Evrf SystemF Care Systems NV20132—
+4K121881Domain Surgical SystemDomain Surgical, Inc.20124—
+4K121678DTADGyrus Acmi, Inc.20122—
+4K112334Vein-Gogh InstrumentRefine USA, LLC20120—
+4K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+4K103775Peak Suction CoagulatorPeak Surgical, Inc.20111—
+4K102709Peak Plasmablade Plus Tissue Dissection DevicePeak Surgical, Inc.20100—
+4K102029Peak Pulsar II Generator Model PS100-102Peak Surgical, Inc.20100—
+4K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+4K093695Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc.20108—
+4K091674Arthrocare Coblator IQ SystemArthrocare Corp.20101—
+4K080844G3 Generator and Accessories-Dissector Plasma KnifeGyrus Acmi, Inc.20091—
+4K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080—
+4K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc.20081—
+4K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+4K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.200514—
+4K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc.20056—
+4K033257Arthrocare Ent Plasma WandsArthrocare Corp.200342—
+5K261202ENTire IRE SystemEntire Medical, Ltd.20260—
+5K251813CURIS II RF Generator (REF 360100-05)Sutter Medizintechnik GmbH20260—
+5K252704F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)F Care Systems USA, LLC20250—
+5K242266PhotonBlade 3; PhotonBlade 3 Smoke EvacuationStryker Instruments20241—
+5K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+5K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+5K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc.20220—
+5K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+5K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+5K200241TempSure SystemCynosure, LLC202013—
+5K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+5K183611Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC20195—
+5K173759Thermage CPT System and AccessoriesSolta Medical201821
+5K170054iSurgJaco, LLC Dba Macan Manufacturing and Bna Burz North America20170—