510(k) Report

Devices descending from K911904

231 later devices reach Models Ues-10 & PSD-10 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K970797Olympus PSD-20 Electrosurgical System and AccessoriesOlympus America, Inc.19972—
+1K970184Olympus Ues-20 Electrosurgical System and Its Associated AccessoriesOlympus America, Inc.1997228—
+2K042274PSD-60/EndoplasmaOlympus Shirakawa Co., Ltd.20050—
+2K021852Olympus PSD-20 Electrosurgical System & Its Associated AccessoriesOlympus Optical Co., Ltd.20030—
+2K023280Olympus PSD-20 Electrosurgical System and Its Associated AccessoriesOlympus Optical Co., Ltd.20020—
+2K023767Ues-30 Electrosurgical Unit and It's Associated AccessoriesThe Olympus Optical Co.200250—
+2K981993Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co.1998175—
+3K050209Smith & Nephew Control Digital Operating Room SystemSmith & Nephew, Inc.20053—
+3K050829Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)20053—
+3K030194Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co.2003493
+3K020255Riwo Net Operating Operating Control System, Model #5590Richard Wolf Medical Instruments Corp.20021—
+3K022270Modification to Olympus Integrated Endosurgery System EndoalphaOlympus Optical Co., Ltd.20028—
+3K994231Siemens Integrated Operating System (Sios)Siemens Medical Corp.2000157—
+4K151282core nova Complete Operating Room EndoscopyRichard Wolf Medical Instruments Corp.20160—
+4K103032Esg-400 Model WB95051N, Footswitch Double Pedal Model WB50402W, Footswitch Single Pedal…Olympus Winter & Ibe GmbH201112—
+4K100816PK Superpulse Sysem Generator Model 744000Gyrus Acmi, Inc.201022—
+4K100275Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection…Olympus Winter & Ibe GmbH2010151
+4K070556Brainsuite NetBrainlab AG20072—
+4K060717Nurse Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)20061—
+4K052202Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc.200615429
+4K052740Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)20052—
+4K041494Olympus Integrated Endosurgery System Endoalpha (Control Unit for Endosurgery Uces-2)…Olympus Corporation20046—
+4K031979Conmed Integrated Systems Nurses AssistantConmed Integrated Systems (Cmis)20030—
+5K222542MCB UNIT Model: V10GMCBUSLamidey Noury Medical20220—
+5K161122Sony IP Converter NU-IP40SSony Electronics, Inc.20161—
+5K152092Resection ElectrodesOlympus Winter & Ibe GmbH201551
+5K141225Esg-400, Footswitch Double Pedal, Footswitch Single Pedal, P-CordOlympus Winter & Ibe GmbH201411—
+5K122716Plasmatrode Saline Safe Tur ElectrodeCook Ireland, Ltd.20130—
+5K120418Electrosugrical Resection and Vaporization Electrode SeriesOlympus Winter & Ibe GmbH201222
+5K120567Gyrus Amci PK Button ElectrodeGyrus Acmi, Inc.20123—
+5K110268Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison201116—
+5K102781Resection Button Electrode for Plasma Vaporization, HF-Resection Electrode Rollers and…Olympus Winter & Ibe GmbH201151
+5K091648Nurse's Assistant O.R. Control System ,1.8Conmed Integrated Systems (Cmis)20090—
+5K073290Artis Zee and ZeegoSiemens Medical Solutions USA, Inc.20087239
+5K061054Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc.2006803
+5K051613Modification to Olympus Integrated Endosurgery System Endoalpha (Control Unit for…Olympus Medical Systems Corporation20055—
+6K221522HF-cables (resusable)Olympus Winter & Ibe GmbH20230—
+6K223039da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20223—
+6K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+6K203682Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and…Olympus Winter & Ibe GmbH20212—
+6K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH202114
+6K191678IP ConverterSony Electronics, Inc.20200—
+6K182587Device Electrosurgical Generator ESG-150Olympus Winter & Ibe GmbH20180—
+6K180200ESG-300, APU-300, Pressure Reducer, MAPC ProbesOlympus Winter & Ibe GmbH20180—
+6K171965Resection Electrodes with HF cableOlympus Winter & Ibe GmbH201731
+6K163090Plasma Edge SystemChirurgie Innovation20172—
+6K161600Resection ElectrodesOlympus Winter & Ibe GmbH20160—
+6K153055ACE Electrosurgical Resection and Vaporization Electrodes SeriesAce Medical Devices Pvt., Ltd.20160—
+6K160639Electrosurgical Generator ESG-200Olympus Winter & Ibe GmbH20160—
+6K152928Multitom RaxSiemens Medical Solutions USA, Inc.201531
+6K151649Valleylab FT10 Electrosurgical PlatformCovidien201510—
+6K143654Valleylab LS10 GeneratorCovidien, LLC20150—
+6K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc.20102439
+6K100852Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000Stryker Communications20102—
+6K100345Systems Integration Model: EndoalphaOlympus Medical Systems Corporation20101—
+6K091166IMRXImris, Inc.20091—
+6K090745Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc.2009697
+6K081722YSIOSiemens Medical Solutions USA, Inc.20084311
+6K080614DR Vision Neo, DR Vision DouAlmana Medical Imaging20080—
+6K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc.20077820
+7K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+7K252412Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)Applied Medical Resources Corporation20250—
+7K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+7K242948Adora DRFi (04550010)Nrt X-Ray A/S20240—
+7K231327POWERSEAL Sealer and DividerGyrus Acmi, Inc.20230—
+7K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+7K231212da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20232—
+7K223060DigiX FDXAllengers Medical Systems Limited20224—
+7K220149General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System…Xera Medical Systems & Technology, Ltd.20220—
+7K213135Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor…Chirurgie Innovation20221—
+7K212643POWERSEAL Curved Jaw Sealer and Divider, Double ActionOlympus Surgical Technologies America202117
+7K210651Resection Electrodes with HF cableOlympus Winter & Ibe GmbH202111
+7K210394Electrosurgical accessoryDornier Medtech America, Inc.20210—
+7K192541DigiX FDXAllengers Medical Systems Limited20195—
+7K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc.2018123
+7K172757Valleylab FX8 Electrosurgical PlatformCovidien, LLC20176—
+7K162529DigiX FDXAllengers Medical Systems Limited20176—
+7K170170Valleylab FT10 Electrosurgical PlatformCovidien, LLC20178—
+7K133292Allura Xper FD; or TablePhilips Medical Systems Nederland B.V.20141545
+7K133259Ysio MaxSiemens Medical Solutions USA, Inc.2014237
+7K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+7K131766Platinum DRF Imaging SystemApelem-Dms Group20132—
+7K131263XperguidePhilips Medical Systems Nederland B.V.20131—
+7K130638Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V.20131839
+7K122644Artis Zee/Zeego with CSX-10 Detector SW VC21Siemens Medical Solutions USA, Inc.2013301
+7K123426Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSSOrpheus Medical, Ltd.20131—
+7K123529Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc.20133331
+7K121513Multix FusionSiemens Medical Solution2012324
+7K113403GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS201264
+7K113034GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare20116—
+7K111912Mobilett MiraSiemens Medical Solutions USA, Inc.201135
+7K111292Luminos AgileSiemens Medical Solutions USA, Inc.201126
+7K102763Systems IntegrationOlympus Medical Systems Corporation20110—
+7K1035061.5T Head Coil (HC150), 3T Head Coil (HC300)Imris, Inc.20110—
+7K101491Uroskop OmniaSiemens Medical Solutions USA, Inc.20101112
+7K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+7K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+7K081073HDR Vision, Vision HDR, HD R/F, Uromat HD R/FPausch, LLC20081—
+7K080859DRF 4343Villa Sistemi Medicali S.P.A.20082—
+8K250660LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions202502