510(k) Report

Devices descending from K962482

56 later devices reach Scuba System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223813Aveta System 2.0Meditrina, Inc.20230—
+1K111751Versapoint II Bipolar Electrosurgery Generator, Versapoint II 44MM Angled Loop…ETHICON, Inc.20111—
+1K990628Gyrus Endourology SystemGyrus Medical, Ltd.199952—
+2K122983Ksea Bipolar ElectrodeKARL STORZ Endoscopy-America, Inc.20130—
+2K122716Plasmatrode Saline Safe Tur ElectrodeCook Ireland, Ltd.20130—
+2K093181Gyrus Acmi PK Button ElectrodeGyrus Acmi, Inc.20104—
+2K030194Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co.2003493
+2K994166Gyrus Endourology System: Axipolar Resectoscope ElectrodeGyrus Medical, Ltd.199916—
+3K163090Plasma Edge SystemChirurgie Innovation20172—
+3K120567Gyrus Amci PK Button ElectrodeGyrus Acmi, Inc.20123—
+3K103032Esg-400 Model WB95051N, Footswitch Double Pedal Model WB50402W, Footswitch Single Pedal…Olympus Winter & Ibe GmbH201112—
+3K100816PK Superpulse Sysem Generator Model 744000Gyrus Acmi, Inc.201022—
+3K100275Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection…Olympus Winter & Ibe GmbH2010151
+3K042274PSD-60/EndoplasmaOlympus Shirakawa Co., Ltd.20050—
+4K222542MCB UNIT Model: V10GMCBUSLamidey Noury Medical20220—
+4K213135Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor…Chirurgie Innovation20221—
+4K152092Resection ElectrodesOlympus Winter & Ibe GmbH201551
+4K141225Esg-400, Footswitch Double Pedal, Footswitch Single Pedal, P-CordOlympus Winter & Ibe GmbH201411—
+4K120418Electrosugrical Resection and Vaporization Electrode SeriesOlympus Winter & Ibe GmbH201222
+4K110268Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison201116—
+4K102781Resection Button Electrode for Plasma Vaporization, HF-Resection Electrode Rollers and…Olympus Winter & Ibe GmbH201151
+5K240504PLASMA EDGE SystemLamidey Noury Medical20240—
+5K221522HF-cables (resusable)Olympus Winter & Ibe GmbH20230—
+5K223039da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20223—
+5K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+5K203682Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and…Olympus Winter & Ibe GmbH20212—
+5K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH202114
+5K182587Device Electrosurgical Generator ESG-150Olympus Winter & Ibe GmbH20180—
+5K180200ESG-300, APU-300, Pressure Reducer, MAPC ProbesOlympus Winter & Ibe GmbH20180—
+5K171965Resection Electrodes with HF cableOlympus Winter & Ibe GmbH201731
+5K161600Resection ElectrodesOlympus Winter & Ibe GmbH20160—
+5K153055ACE Electrosurgical Resection and Vaporization Electrodes SeriesAce Medical Devices Pvt., Ltd.20160—
+5K160639Electrosurgical Generator ESG-200Olympus Winter & Ibe GmbH20160—
+5K151649Valleylab FT10 Electrosurgical PlatformCovidien201510—
+5K143654Valleylab LS10 GeneratorCovidien, LLC20150—
+6K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+6K252412Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)Applied Medical Resources Corporation20250—
+6K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+6K231327POWERSEAL Sealer and DividerGyrus Acmi, Inc.20230—
+6K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+6K231212da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20232—
+6K212643POWERSEAL Curved Jaw Sealer and Divider, Double ActionOlympus Surgical Technologies America202117
+6K210651Resection Electrodes with HF cableOlympus Winter & Ibe GmbH202111
+6K210394Electrosurgical accessoryDornier Medtech America, Inc.20210—
+6K172757Valleylab FX8 Electrosurgical PlatformCovidien, LLC20176—
+6K170170Valleylab FT10 Electrosurgical PlatformCovidien, LLC20178—
+7K241635da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20241—
+7K221893KARL STORZ Bipolar Resectoscopes with HF CableKarl Storz Endoscopy America, Inc.20230—
+7K213354Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection…Conmed Corporation20220—
+7K181389Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy PlatformCovidien20185—
+8K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.20260—
+8K241138ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing…Livsmed, Inc.20241—
+8K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device…Medtronic20182—
+9K250126ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Livsmed, Inc.20250—
+9K191601Valleylab FT10 Electrosurgical PlatformCovidien201911
+10K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC20240—