510(k) Report

Devices descending from K933157

144 later devices reach Erbotom Icc 200 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113265Genii GI 4000 Electrosugical GeneratorGenii, Inc.20121—
+1K100669Canady Plasma Electrosurgical Unit Series with Accessory Probes and BladesUs Medical Innovations, LLC20112—
+1K081678Conmed Beamer System C600Kls Martin GmbH + Co. KG20081—
+1K073207Olympus Esg-100, Model WB991046; Olympus Afu-100, Model WB950167Celon AG Medical Instruments200871
+1K062712Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094Erbe USA, Inc.200714—
+1K061884Bovie Icon GI Electrosurgical Generator, Model GI 120Bovie Medical20062—
+1K013255Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc.2001104—
+1K992382Surgitron RadiolaseEllman Intl., Inc.19997—
+2K250657gi2000 Electrosurgical GeneratorCintron Medical Corporation20250—
+2K200931RF Surgical GeneratorFulwell, LLC20200—
+2K192124Canady Plasma SMART XL-1000 Electrosurgical Generator with AccessoriesUs Medical Innovations, LLC20191—
+2K123366Surgitron 4.0 Dual RF S5-IecEllman International, Inc.2013161
+2K122092Medrange Electrosurgical Expansion SystemMedrange Corporation20120—
+2K113119Endogator Advantage Irrigation PumpByrne Medical, Inc.20122—
+2K100899Olympus Endoscopic Flushing Pump, Model Opf-2Keymed (Medical & Industrial Equipment), Ltd.201013
+2K083608Erbe Hybrid KnifeErbe USA, Inc.200913—
+2K082834Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc.2009561
+2K082109Bovie Icon General Purpose RF GeneratorBovie Medical20081—
+2K073057Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection Device, Model…Peak Surgical, Inc.200833—
+2K061174Surgi-MaxEllman Int'L, Inc.200635—
+2K051956DR. Oppel ST-501Sometech Incorporated20051—
+2K042710Surgitron Radiolase IIEllman Int'L, Inc.20050—
+2K014216Secca SystemCuron Medical, Inc.20025—
+3K241704Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd.20250—
+3K240297Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)Us Medical Innovations, LLC20240—
+3K232033HYBRIDknife® flexErbe Elektromedizin GmbH20230—
+3K210618Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation…Chongqing Jinshan Science & Technology Co., Ltd.20210—
+3K200404ORISE ProKnifeBoston Scientific Corporation20200—
+3K182365TempSure SystemCynosure, Inc.201815—
+3K181257PlasmaBlade X 3.0S, PlasmaBlade X 4.0Medtronic Advanced Energy20183—
+3K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp.201772
+3K152278ENDOFLOW II - Irrigation, Warming and Suction SystemPromepla Sam20160—
+3K143306ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc.201512—
+3K134036Wavetronic 5000 Digital HF Surgical UnitLoktal Medical Electronics Ind. Com. Ltda- Epp20150—
+3K130689Symphony RF GeneratorThermigen, Inc.201311—
+3K122966XP200Btl Industries, Ltd.20131—
+3K110143Het Bipolar Electrocautery ForcepsHet Systems, LLC20113—
+3K103017Mederi Therapeutics RF Generator Control ModuleMederi Therapeutics, Inc.20110—
+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—
+3K092383Bovie Icon VS General Purpose RF Generator, Model: VS300Bovie Medical Corporation20100—
+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
+4K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife…Olympus Medical Systems Corporation20250—
+4K243120HybridAPC probeErbe Elektromedizin GmbH20251—
+4K240311JETT Medical IICompex, Spol, S.R.O.20250—
+4K231023ERBEJET® 2 SystemErbe Elektromedizin GmbH20231—
+4K212999Multi-Functional Electrosurgical KnifeAnrei Medical (Hangzhou) Co., Ltd.20220—
+4K210077MED RF 4000F Care Systems USA, LLC20211—
+4K193601Single Use Electrosurgical KnifeMicro-Tech (Nanjing) Co., Ltd.20201—
+4K192342Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare…Hangzhou AGS MedTech Co., Ltd.20200—
+4K193579PlasmaBlade X 3.0S LIGHTMedtronic Navigation20202—
+4K190678TempSureCynosure, Inc.201914—
+4K182408Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645Olympus Medical Systems Corp.201913
+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—
+4K152703PlasmaBlade TnA Tonsil and Adenoid Dissection DeviceMedtronic Advanced Energy20160—
+4K160041Cobbra RF Tissue DissectorElliquence, LLC20166—
+4K151793InMode RF SystemInmode MD, Ltd.20161—
+4K152702Ent Biotech Solutions Tissue Removal Device (Elasso)Ent Biotech Solutions20160—
+4K142410Elliquence ElectrodesElliquence, LLC20157—
+4K150297PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy20150—
+4K143109XP300BTL Industries, Inc.20150—
+4K143175AEx Generator; PlasmaBlade TMedtronic Advanced Energy20141—
+4K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+4K132431Thermage CPT SystemSolta Medical, Inc.2013171
+4K130283Evrf SystemF Care Systems NV20132—
+4K121085Het Bipolar Ligator SystemHet Systems, LLC20122—
+4K121881Domain Surgical SystemDomain Surgical, Inc.20124—
+4K121678DTADGyrus Acmi, Inc.20122—
+4K112334Vein-Gogh InstrumentRefine USA, LLC20120—
+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—
+5K251813CURIS II RF Generator (REF 360100-05)Sutter Medizintechnik GmbH20260—
+5K253915MOVIVA® Hybrid Ablation ProbeErbe Elektromedizin GmbH20250—
+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—
+5K211172Single Use Electrosurgical Knife with Fluid Pump SystemMicro-Tech (Nanjing) Co., Ltd.20210—
+5K200241TempSure SystemCynosure, LLC202013—
+5K183611Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC20195—
+5K173759Thermage CPT System and AccessoriesSolta Medical201821
+5K170054iSurgJaco, LLC Dba Macan Manufacturing and Bna Burz North America20170—
+5K170758Thermage FLX System and AccessoriesSolta Medical201713—
+5K171262TempSureCynosure, Inc.201716—
+5K170610PlasmaBlade TMedtronic Advanced Energy20170—
+5K170116Thermi Injectable RF ElectrodesThermi20172—
+5K163190InMode RF SystemInmode MD, Ltd.20160—
+5K162053PhotonBladeInvuity, Inc.201611
+5K140422Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC20141—
+5K130606Fmwand Ferromagnetic Surgical SystemDomain Surgical, Inc.20143—