510(k) Report

Devices descending from K003060

120 later devices reach Plasmakinetic Generator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031085Gyrus Plasmakinetic Superpulse System (Generator, Accessories)Gyrus Medical, Inc.200357—
+1K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC200276—
+2K121977Plasmajet Neutral Plasma Surgery SystemPlasma Surgical Limited20121—
+2K100816PK Superpulse Sysem Generator Model 744000Gyrus Acmi, Inc.201022—
+2K100275Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection…Olympus Winter & Ibe GmbH2010151
+2K093181Gyrus Acmi PK Button ElectrodeGyrus Acmi, Inc.20104—
+2K082054Gyrus Acmi Plasmakinetic (PK) Superpulse System, Model 744000 and Dual Footswitch…Gyrus Acmi, Inc.200823—
+2K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.200514—
+2K041633Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc.20048—
+2K041285Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision…Gyrus Medical, Ltd.2004202
+2K033027Shinmed Various Models of Electro-Surgical Pencils, SW12200, SW12202, SW12300Shining World Health Care Co., Ltd.20042—
+2K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC200450—
+3K253917ARION ARC SystemPlasma Surgical, Inc.20260—
+3K222542MCB UNIT Model: V10GMCBUSLamidey Noury Medical20220—
+3K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+3K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+3K152092Resection ElectrodesOlympus Winter & Ibe GmbH201551
+3K142289PK SpatulaGyrus Acmi, Inc.20141—
+3K122716Plasmatrode Saline Safe Tur ElectrodeCook Ireland, Ltd.20130—
+3K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+3K121678DTADGyrus Acmi, Inc.20122—
+3K120567Gyrus Amci PK Button ElectrodeGyrus Acmi, Inc.20123—
+3K120418Electrosugrical Resection and Vaporization Electrode SeriesOlympus Winter & Ibe GmbH201222
+3K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+3K110268Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison201116—
+3K102781Resection Button Electrode for Plasma Vaporization, HF-Resection Electrode Rollers and…Olympus Winter & Ibe GmbH201151
+3K100896Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc.201031
+3K092634Obs Disposable Electrosurgical Pencils, Models: Obs-DB, Obs-DR, Obs-DFJiangmen City Xinhui Baisheng Medical Equipment CO20091—
+3K080844G3 Generator and Accessories-Dissector Plasma KnifeGyrus Acmi, Inc.20091—
+3K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080—
+3K081766PKS Omni InstrumentGyrus-Acmi L.P.200831
+3K081954Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector CableGyrus Acmi, Inc.20080—
+3K071759LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand…Live Tissue Connect, Inc.20080—
+3K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc.20081—
+3K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+3K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc.20056—
+4K221522HF-cables (resusable)Olympus Winter & Ibe GmbH20230—
+4K223039da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20223—
+4K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc.20220—
+4K170369Disposable Electrosurgical PencilsCathay Manfacturing Corp.20180—
+4K171965Resection Electrodes with HF cableOlympus Winter & Ibe GmbH201731
+4K163090Plasma Edge SystemChirurgie Innovation20172—
+4K161038PK MorcellatorGyrus Acmi, Inc.20160—
+4K161825PK AIMGyrus Acmi, Inc.20162—
+4K161600Resection ElectrodesOlympus Winter & Ibe GmbH20160—
+4K153055ACE Electrosurgical Resection and Vaporization Electrodes SeriesAce Medical Devices Pvt., Ltd.20160—
+4K151649Valleylab FT10 Electrosurgical PlatformCovidien201510—
+4K143654Valleylab LS10 GeneratorCovidien, LLC20150—
+4K142759PK Cutting Forceps for ESG-400 WorkstationGyrus Acmi, Inc.20152—
+4K142350PK J-HookGyrus Acmi, Inc.201511
+4K142525PK Lap LoopOlympus Winter & Ibe GmbH20140—
+4K131205Arthrocare Head and Neck Coblation WandArthroCare Corporation20130—
+4K130305Lina Bipolar Loop; Standard Size, Large Size, Extra Large SizeLina Medical Aps20130—
+4K122605PKS BillGyrus Acmi, Inc.20121—
+4K102366Finess EndoscopeEntellus Medical, Inc.20110—
+4K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc.200842—
+5K252412Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)Applied Medical Resources Corporation20250—
+5K231212da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20232—
+5K213135Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor…Chirurgie Innovation20221—
+5K210651Resection Electrodes with HF cableOlympus Winter & Ibe GmbH202111
+5K210394Electrosurgical accessoryDornier Medtech America, Inc.20210—
+5K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH202114
+5K172757Valleylab FX8 Electrosurgical PlatformCovidien, LLC20176—
+5K170170Valleylab FT10 Electrosurgical PlatformCovidien, LLC20178—
+5K163373PK AIMGyrus Acmi, Inc.20161—
+5K102003Xpress Balloon DeviceEntellus Medical, Inc.201036—
+5K093007Entellus Medical Balloon DeviceEntellus Medical, Inc.201041—
+6K241635da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20241—
+6K240504PLASMA EDGE SystemLamidey Noury Medical20240—
+6K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+6K221893KARL STORZ Bipolar Resectoscopes with HF CableKarl Storz Endoscopy America, Inc.20230—
+6K213354Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection…Conmed Corporation20220—
+6K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+6K181389Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy PlatformCovidien20185—
+6K170908PK AIMGyrus Acmi, Inc.20170—
+6K132297EM Sinus Dilation SystemMedtronic Xomed, Inc.20135—
+6K120280Relieva Seeker Balloon Sinuplasty SystemAcclarent, Inc.20122—
+6K121351Sinus Dilation SystemEntrigue Surgical, Inc.20128—
+6K112506Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201121—
+6K111875Relieva Spin Sinus Dilation SystemAcclarent, Inc.20117—
+6K111254Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc.20117—
+6K110158Illuminating Sinus SeekerEntellus Medical, Inc.20113—
+7K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.20260—
+7K241138ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing…Livsmed, Inc.20241—
+7K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+7K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+7K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device…Medtronic20182—
+7K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—
+7K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+7K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+7K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.20150—
+7K143738DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC20150—
+7K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc.20152—
+7K140160Relieva Scout Sinus Dilation SystemAcclarent, Inc.20140—
+7K133016Vent-OS Sinus Dilation SystemSinusys Corporation20130—
+7K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp.20130—
+7K121174Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201220—
+7K113522Pathassist Light SeekerEntellus Medical, Inc.20122—
+8K250126ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Livsmed, Inc.20250—
+8K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—