510(k) Report

Devices descending from K051644

128 later devices reach Valleylab Forcetriad Electrosurgical Generator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182365TempSure SystemCynosure, Inc.201815—
+1K171262TempSureCynosure, Inc.201716—
+1K111202Surgical Tissue Management SystemOlympus Medical Systems Corp.20121110
+1K110268Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison201116—
+1K102913ForcetriadCovidien, Formerly Valleylab, A Division of Tyco H20111—
+1K081129Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD…Surgrx, Inc.200824—
+1K070162Forcetriad Electrosurgical Generator; Ligasure InstrumentsValleylab,A Division of Tyco Healthcare Group LP2007102—
+2K223039da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20223—
+2K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+2K190678TempSureCynosure, Inc.201914—
+2K172691Ultrasonic GeneratorOlympus Medical Systems Corp.20174—
+2K160602JustRight Surgical Vessel Sealing SystemJustright Surgical20166—
+2K151649Valleylab FT10 Electrosurgical PlatformCovidien201510—
+2K143654Valleylab LS10 GeneratorCovidien, LLC20150—
+2K141288Voyant Electrosurgical Generator, Voyant 5MM Laparoscopic Sealer-Divider DeviceApplied Medical Resources20149—
+2K132703ThunderbeatOlympus Medical Systems Corp.20149—
+2K123662The Justright Surgical Vessel Sealing SystemJustright Surgical, LLC20137—
+2K123444Ligasure Impact Curved, Large Jaw, Open Sealer / DividerCovidien, Formerly Valleylab, A Division of Tyco H201356—
+2K120040Reprocessed Surgical Electric InstrumentSterilmed, Inc.20120—
+2K111600Reprocessed Hand Activate Sealer/DividerAscent Healthcare Solutions20110—
+2K110824Aragon Surgical RF System - 5MM Laparoscopic InstrumentAragon Surgical, Inc.20117—
+2K110695Bipolar HF DeviceAesculap, Inc.20110—
+2K101990Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC201111—
+3K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+3K252412Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)Applied Medical Resources Corporation20250—
+3K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+3K242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic…Shanghai Saints Sages Surgical Co., Ltd.20250—
+3K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+3K231212da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20232—
+3K203183CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)Bolder Surgical, LLC20212—
+3K203640CoolSeal RevealBolder Surgical, LLC20210—
+3K202114CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal…Bolder Surgical, LLC202041
+3K200241TempSure SystemCynosure, LLC202013—
+3K193292Voyant 5mm Fusion Device, Voyant Maryland Fusion DeviceApplied Medical Resources Corp.20194—
+3K182244Voyant Electrosurgical GeneratorApplied Medical Resources Corp.20181—
+3K180575THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.20180—
+3K172610THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.201843
+3K172624Voyant 5mm Fusion DeviceApplied Medical Resources Corporation20186—
+3K172757Valleylab FX8 Electrosurgical PlatformCovidien, LLC20176—
+3K170170Valleylab FT10 Electrosurgical PlatformCovidien, LLC20178—
+3K162676Voyant Open Fusion DeviceApplied Medical Resources20163—
+3K162047LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coatedCovidien20163—
+3K160554Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20166—
+3K153745Medline ReNewal Reprocessed LigaSure Impact Open Sealer/DividerSurgical Instrument Service and Savings Inc.(Dba Medline Ren201604
+3K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+3K150538Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/DividerStryker Sustainability Solutions20150—
+3K143517Voyant Open Sealer-Divider DeviceApplied Medical Resources201511
+3K141122Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC20149—
+3K141153Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw…Covidien201440—
+3K130596Caiman Seal and Cut TechnologyAesculap, Inc.20136—
+4K253634CoolSeal Generator® (CSL-200-90)Hologic, Inc.20260—
+4K252487POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)Gyrus Acmi, Inc.20260—
+4K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+4K241635da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20241—
+4K212614Ultrasonic Scalpel SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20221—
+4K212891TempSure SystemCynosure, LLC20221—
+4K213354Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection…Conmed Corporation20220—
+4K211639BTL-785WBTL Industries, Inc.20227—
+4K211579CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm…Bolder Surgical, LLC20211—
+4K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+4K203682Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and…Olympus Winter & Ibe GmbH20212—
+4K203461Aesculap Caiman 12 Seal and Cut Technology SystemAesculap, Inc.20200—
+4K201212Voyant Open Fusion DeviceApplied Medical Resources Corp.20201—
+4K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+4K200841Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11Ethicon Endo-Surgery, LLC20204—
+4K200598Voyant Maryland Fusion DeviceApplied Medical Resources Corp.20201—
+4K182653Voyant Maryland Fusion DeviceApplied Medical Resources Corp.20185—
+4K182588Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/DividerSurgical Instrument Service and Savings Inc.(Dba Medline Ren201805
+4K181085LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coatedCovidien20181—
+4K181389Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy PlatformCovidien20185—
+4K180699Voyant Open Fusion DeviceApplied Medical Resources Corporation20182—
+4K172856Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/DividerStryker Sustainability Solutions20170—
+4K170908PK AIMGyrus Acmi, Inc.20170—
+4K170869LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coatedCovidien201711—
+4K163548ENSEAL X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20170—
+4K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien201641
+4K161804LigaSure Retractable L-Hook Laparoscopic Sealer/DividerCovidien20160—
+4K160331LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable…Covidien20160—
+4K153288Voyant Open Fusion DeviceApplied Medical Resources20160—
+4K152286LigaSure Curved, Small Jaw, Open Sealer/DividerCovidien201514—
+4K151696Caiman Seal and Cut TechnologyAesculap, Inc.20152—
+4K142929Ligasure Blunt Tip Sealer/DividerCovidien20156—
+4K140839Caiman Seal and Cut TechnologyAesculap, Inc.20141—
+5K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC20260—
+5K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC20260—
+5K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.20260—
+5K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+5K252740Voyant® Open Fusion Device (EB240/Open Fusion)Applied Medical Resources Corp.20250—
+5K243067The ETHICON™ Total Energy SystemEthicon Endo-Surgery, LLC (A Johnson and Johnson Company)20250—
+5K241138ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing…Livsmed, Inc.20241—
+5K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…Stryker Sustainability Solutions20240—
+5K233036Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd.20240—
+5K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…Stryker Sustainability Solutions20241—
+5K231012CoolSeal TrinityBolder Surgical, LLC20230—
+5K231327POWERSEAL Sealer and DividerGyrus Acmi, Inc.20230—
+5K231732CleanSeal Advanced Bipolar Vessel Sealer MarylandConmed Corporation20230—
+5K222556BTL-785XBTL Industries, Inc.20235—
+5K223158LigaSure™ XP Maryland Jaw Sealer/DividerCovidien, LLC20231—
+5K223292TempSure SystemCynosure, LLC20220—
+5K222284Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)Applied Medical Resources Corporation20220—