510(k) Report

Devices descending from K031085

57 later devices reach Gyrus Plasmakinetic Superpulse System (Generator, Accessories) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121977Plasmajet Neutral Plasma Surgery SystemPlasma Surgical Limited20121—
+1K100816PK Superpulse Sysem Generator Model 744000Gyrus Acmi, Inc.201022—
+1K100275Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection…Olympus Winter & Ibe GmbH2010151
+1K093181Gyrus Acmi PK Button ElectrodeGyrus Acmi, Inc.20104—
+1K082054Gyrus Acmi Plasmakinetic (PK) Superpulse System, Model 744000 and Dual Footswitch…Gyrus Acmi, Inc.200823—
+1K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.200514—
+1K033027Shinmed Various Models of Electro-Surgical Pencils, SW12200, SW12202, SW12300Shining World Health Care Co., Ltd.20042—
+2K253917ARION ARC SystemPlasma Surgical, Inc.20260—
+2K222542MCB UNIT Model: V10GMCBUSLamidey Noury Medical20220—
+2K152092Resection ElectrodesOlympus Winter & Ibe GmbH201551
+2K122716Plasmatrode Saline Safe Tur ElectrodeCook Ireland, Ltd.20130—
+2K120567Gyrus Amci PK Button ElectrodeGyrus Acmi, Inc.20123—
+2K120418Electrosugrical Resection and Vaporization Electrode SeriesOlympus Winter & Ibe GmbH201222
+2K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+2K110268Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison201116—
+2K102781Resection Button Electrode for Plasma Vaporization, HF-Resection Electrode Rollers and…Olympus Winter & Ibe GmbH201151
+2K100896Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc.201031
+2K092634Obs Disposable Electrosurgical Pencils, Models: Obs-DB, Obs-DR, Obs-DFJiangmen City Xinhui Baisheng Medical Equipment CO20091—
+2K081766PKS Omni InstrumentGyrus-Acmi L.P.200831
+2K081954Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector CableGyrus Acmi, Inc.20080—
+2K071759LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand…Live Tissue Connect, Inc.20080—
+3K221522HF-cables (resusable)Olympus Winter & Ibe GmbH20230—
+3K223039da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20223—
+3K170369Disposable Electrosurgical PencilsCathay Manfacturing Corp.20180—
+3K171965Resection Electrodes with HF cableOlympus Winter & Ibe GmbH201731
+3K163090Plasma Edge SystemChirurgie Innovation20172—
+3K161825PK AIMGyrus Acmi, Inc.20162—
+3K161600Resection ElectrodesOlympus Winter & Ibe GmbH20160—
+3K153055ACE Electrosurgical Resection and Vaporization Electrodes SeriesAce Medical Devices Pvt., Ltd.20160—
+3K151649Valleylab FT10 Electrosurgical PlatformCovidien201510—
+3K143654Valleylab LS10 GeneratorCovidien, LLC20150—
+3K142759PK Cutting Forceps for ESG-400 WorkstationGyrus Acmi, Inc.20152—
+3K142525PK Lap LoopOlympus Winter & Ibe GmbH20140—
+3K130305Lina Bipolar Loop; Standard Size, Large Size, Extra Large SizeLina Medical Aps20130—
+3K122605PKS BillGyrus Acmi, Inc.20121—
+4K252412Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)Applied Medical Resources Corporation20250—
+4K231212da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20232—
+4K213135Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor…Chirurgie Innovation20221—
+4K210651Resection Electrodes with HF cableOlympus Winter & Ibe GmbH202111
+4K210394Electrosurgical accessoryDornier Medtech America, Inc.20210—
+4K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH202114
+4K172757Valleylab FX8 Electrosurgical PlatformCovidien, LLC20176—
+4K170170Valleylab FT10 Electrosurgical PlatformCovidien, LLC20178—
+4K163373PK AIMGyrus Acmi, Inc.20161—
+5K241635da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20241—
+5K240504PLASMA EDGE SystemLamidey Noury Medical20240—
+5K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+5K221893KARL STORZ Bipolar Resectoscopes with HF CableKarl Storz Endoscopy America, Inc.20230—
+5K213354Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection…Conmed Corporation20220—
+5K181389Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy PlatformCovidien20185—
+5K170908PK AIMGyrus Acmi, Inc.20170—
+6K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.20260—
+6K241138ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing…Livsmed, Inc.20241—
+6K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device…Medtronic20182—
+7K250126ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Livsmed, Inc.20250—
+7K191601Valleylab FT10 Electrosurgical PlatformCovidien201911
+8K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC20240—