510(k) Report

Devices descending from K100816

22 later devices reach PK Superpulse Sysem Generator Model 744000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222542MCB UNIT Model: V10GMCBUSLamidey Noury Medical20220—
+1K120567Gyrus Amci PK Button ElectrodeGyrus Acmi, Inc.20123—
+1K110268Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison201116—
+2K223039da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20223—
+2K163090Plasma Edge SystemChirurgie Innovation20172—
+2K151649Valleylab FT10 Electrosurgical PlatformCovidien201510—
+2K143654Valleylab LS10 GeneratorCovidien, LLC20150—
+3K252412Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)Applied Medical Resources Corporation20250—
+3K231212da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20232—
+3K213135Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor…Chirurgie Innovation20221—
+3K172757Valleylab FX8 Electrosurgical PlatformCovidien, LLC20176—
+3K170170Valleylab FT10 Electrosurgical PlatformCovidien, LLC20178—
+4K241635da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20241—
+4K240504PLASMA EDGE SystemLamidey Noury Medical20240—
+4K213354Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection…Conmed Corporation20220—
+4K181389Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy PlatformCovidien20185—
+5K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.20260—
+5K241138ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing…Livsmed, Inc.20241—
+5K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device…Medtronic20182—
+6K250126ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Livsmed, Inc.20250—
+6K191601Valleylab FT10 Electrosurgical PlatformCovidien201911
+7K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC20240—