510(k) Report

Devices descending from K944602

319 later devices reach Valleylab Force FX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250657gi2000 Electrosurgical GeneratorCintron Medical Corporation20250—
+1K223784Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200Deltronix Equipamentos Ltda20230—
+1K210488Ultrasonic Surgical & Electrosurgical GeneratorSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20210—
+1K183564Electrosurgical GeneratorFulwell, LLC20190—
+1K162034OBS Electrosurgical Generator (Model: OBS-350A)Baisheng Medical Co., Ltd.20170—
+1K143161Force FX-8(S), Force FX-8C (S), Force FX-8CA (S)Covidien20142—
+1K130760Electrosurgical GeneratorBeijing Jinhengwei Technology Development Co., Ltd.20130—
+1K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+1K111285Aquamantys 3 Pump Generator, Bipolar Sealer, Bipolar Sealer with CuttingSalient Surgical Technologies, Inc.201131
+1K100669Canady Plasma Electrosurgical Unit Series with Accessory Probes and BladesUs Medical Innovations, LLC20112—
+1K102114Medrange Electrosurgical GeneratorMedrange Corporation20102—
+1K053510IR Wireless Foot SwitchLinemaster Switch Corp.2006122
+1K052009Conmed System Model 2450 Electrosurgical GeneratorConmed Corporation200535
+1K051644Valleylab Forcetriad Electrosurgical GeneratorValleylab2005128—
+1K050579Mega Power Electrosurgical GeneratorMegadyne Medical Products, Inc.2005161
+1K030473Senorx ES-300Senorx, Inc.20030—
+1K022856Bovie Ids-300 High Frequency Electrosurgical GeneratorAaron Medical Industries200348—
+1K014172Nelson Electrosurgical Unit, Model GN640Aesculap, Inc.20020—
+1K012799ES-2000 Shape Select Electrosurgical ScalpelSenorx, Inc.20012—
+1K991140Oratec Interventions Vulcan Eas Electrothermal Arthroscopy System and AccessoriesOratec Interventions, Inc.19991—
+1K981916Ligasure Vessel Sealing SystemValleylab, Inc.1998202—
+1K981724O.R.Pro 300 Electrosurgical Generator Model 40001-100Medtrex, Inc.199834—
+2K223932SafeAir combi (SFR-combi-US)Lina Medical Aps20230—
+2K211203Green OR Reprocessed Aquamantys Bipolar SealerGreen Or, LLC20220—
+2K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+2K201221Electrosurgical GeneratorNew Deantronics Taiwan, Ltd.20200—
+2K201224Electrosurgical Generator and AccessoriesMedrange20201—
+2K193145Ethicon Megadyne Electrosurgical Generator, Bipolar FootswitchMegadyne Medical Products, Inc.20202—
+2K192124Canady Plasma SMART XL-1000 Electrosurgical Generator with AccessoriesUs Medical Innovations, LLC20191—
+2K191328Megadyne Foot SwitchMegadyne Medical Products, Inc.20190—
+2K182365TempSure SystemCynosure, Inc.201815—
+2K171262TempSureCynosure, Inc.201716—
+2K160331LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable…Covidien20160—
+2K160602JustRight Surgical Vessel Sealing SystemJustright Surgical20166—
+2K140459Altrus Thermal Tissue Fusion Energy Source, Altrus Thermal Tissue Fusion Handpiece…Conmed Corporation201401
+2K134054Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High Frequency…Bovie Medical Corporation201439—
+2K123662The Justright Surgical Vessel Sealing SystemJustright Surgical, LLC20137—
+2K121290AQUAMANTRYS3 BSC 9.1SMedtronic, Inc.20120—
+2K120537AQUAMANTYS3 9.5 XL Bipolar SealerMedtronic, Inc.20121—
+2K111202Surgical Tissue Management SystemOlympus Medical Systems Corp.20121110
+2K110824Aragon Surgical RF System - 5MM Laparoscopic InstrumentAragon Surgical, Inc.20117—
+2K110268Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison201116—
+2K102913ForcetriadCovidien, Formerly Valleylab, A Division of Tyco H20111—
+2K103665Conmed R Sabre Genesis TM Electrosurgical Unit; Coned R Sabre Genesis TM Electrosurgical…Conmed Corporation20112—
+2K101534Conmed Altrus Thermal Tissue Fusion SystemConmedcorp201018
+2K100638Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214Depuy Mitek, A Johnson & Johnson Company20108—
+2K090306Aragon Surgical RF System L2 InstrumentAragon Surgical, Inc.20099—
+2K083161Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100)Conmed Linvatec20099—
+2K081312Aragon Oneshot SystemAragon Surgical, Inc.200810—
+2K082109Bovie Icon General Purpose RF GeneratorBovie Medical20081—
+2K071759LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand…Live Tissue Connect, Inc.20080—
+2K081129Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD…Surgrx, Inc.200824—
+2K073057Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection Device, Model…Peak Surgical, Inc.200833—
+2K072041Bovie Ids-400 Electrosurgical GeneratorBovie Medical20081—
+2K070275Flexible Loop Electrosurgical ElectrodeRubicor Medical, Inc.20070—
+2K070162Forcetriad Electrosurgical Generator; Ligasure InstrumentsValleylab,A Division of Tyco Healthcare Group LP2007102—
+2K062074Iridex Wireless FootswitchIridex Corp20060—
+2K061884Bovie Icon GI Electrosurgical Generator, Model GI 120Bovie Medical20062—
+2K060170Erbe Biclamp Open and Laparoscopic InstrumentsErbe USA, Inc.20060—
+2K043273Ligasure Vessel Sealing System. Ligasure InstrumentsValleylab200537—
+2K033421Erbe Biclamp Open and Laparoscopic InstrumentsErbe USA, Inc.20042—
+2K024286Gyrus Open ForcepsGyrus Medical, Inc.2003146
+2K031133Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal Controller…Surgrx, Inc.200356—
+2K031011Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc.20031142
+2K021707Single Step Biopsy Device, Single Step Surgical Handle, Single Step Driver, Single Step…Senorx, Inc.20020—
+2K012679Reprocessed RF Arthroscopy ProbesSterilmed, Inc.200101
+3K253777Ascblue (8010)Ascblue Corporation20260—
+3K243067The ETHICON™ Total Energy SystemEthicon Endo-Surgery, LLC (A Johnson and Johnson Company)20250—
+3K240975Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)Beijing Taktvoll Technology Co., Ltd.20240—
+3K240297Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)Us Medical Innovations, LLC20240—
+3K223039da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20223—
+3K213696ETHICON Megadyne Electrosurgical GeneratorMegadyne Medical Products, Inc.20220—
+3K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+3K203183CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)Bolder Surgical, LLC20212—
+3K203640CoolSeal RevealBolder Surgical, LLC20210—
+3K202114CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal…Bolder Surgical, LLC202041
+3K190678TempSureCynosure, Inc.201914—
+3K183611Soniquence RF Generator and Soniquence ElectrodesSoniquence, LLC20195—
+3K181257PlasmaBlade X 3.0S, PlasmaBlade X 4.0Medtronic Advanced Energy20183—
+3K173740Reprocessed DePuy Mitek Ablation WandRenovo, Inc.20180—
+3K172691Ultrasonic GeneratorOlympus Medical Systems Corp.20174—
+3K170107Surgi Max UltraElliquence, LLC20177—
+3K162656ESU-1 Electrosurgical GeneratorTva Medical, Inc.20161—
+3K161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator…Bovie Medical Corporation201614—
+3K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation201632
+3K151649Valleylab FT10 Electrosurgical PlatformCovidien201510—
+3K143475VAPR Tripolar Suction ElectrodeDepuy Mitek201501
+3K143654Valleylab LS10 GeneratorCovidien, LLC20150—
+3K142229Laparoscopic FMsealerDomain Surgical, Inc.20150—
+3K142975Bovie Ultimate High Frequency Electrosurgical GeneratorBovie Medical Corporation201412—
+3K141288Voyant Electrosurgical Generator, Voyant 5MM Laparoscopic Sealer-Divider DeviceApplied Medical Resources20149—
+3K140896Vapr Arctic Suction ElectrodeDepuy Mitek, A Johnson & Johnson Company20140—
+3K141484Open FmsealerDomain Surgical, Inc.201411
+3K140578Arthroscopic Energy SystemConmed Corporation201411
+3K132703ThunderbeatOlympus Medical Systems Corp.20149—
+3K130596Caiman Seal and Cut TechnologyAesculap, Inc.20136—
+3K123444Ligasure Impact Curved, Large Jaw, Open Sealer / DividerCovidien, Formerly Valleylab, A Division of Tyco H201356—
+3K123096Reprocessed Vessel SealerSterilmed, Inc.20131—
+3K120040Reprocessed Surgical Electric InstrumentSterilmed, Inc.20120—
+3K120095Side Effect with Hand Controls, Hook Electrode with Hand Controls, 2.3 Wedge Electrode…Depuy Mitek, A Johnson & Johnson Company20120—