510(k) Report

Devices descending from K981916

202 later devices reach Ligasure Vessel Sealing System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K172610THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.201843
+4K173281LigaSure Exact Dissector, Nano-coatedCovidien20185—
+4K172624Voyant 5mm Fusion DeviceApplied Medical Resources Corporation20186—
+4K172757Valleylab FX8 Electrosurgical PlatformCovidien, LLC20176—
+4K162751Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/DividerSurgical Instrument Services and Savings, Inc.201701
+4K170869LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coatedCovidien201711—
+4K170170Valleylab FT10 Electrosurgical PlatformCovidien, LLC20178—
+4K163373PK AIMGyrus Acmi, Inc.20161—
+4K162676Voyant Open Fusion DeviceApplied Medical Resources20163—
+4K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien201641
+4K162047LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coatedCovidien20163—
+4K160554Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20166—
+4K153017Voyant Fine FusionApplied Medical Resources20161—
+4K160539BiZact Open Sealer/DividerCovidien20163—
+4K153745Medline ReNewal Reprocessed LigaSure Impact Open Sealer/DividerSurgical Instrument Service and Savings Inc.(Dba Medline Ren201604
+4K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+4K152134Reprocessed Vessel SealerSterilmed, Inc.20160—
+4K151858Caiman Seal and Cut TechnologyAesculap, Inc.201501
+4K150538Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/DividerStryker Sustainability Solutions20150—
+4K142208Monopolar Laparascopic AccessoriesUnimicro Medical Systems (Shenzhen) Co., Ltd.20151—
+4K143517Voyant Open Sealer-Divider DeviceApplied Medical Resources201511
+4K142929Ligasure Blunt Tip Sealer/DividerCovidien20156—
+4K1428685mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm…Purple Surgical International Limited20140—
+4K123329DA Vinvi Surgical SystemIntuitive Surgical, Inc.20143—
+4K141122Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC20149—
+4K141153Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw…Covidien201440—
+4K140189Endowrist Vessel SealerIntuitive Surgical, Inc.201491
+4K131435Enseal G2 Tissue Sealer, Straight Jaw, Enseal G2 Tissue Sealer, Curved Jaw, Enseal Trio…Ethicon Endo-Surgery, LLC20135—
+4K123260Detachatip IiiConmed Corporation20120—
+4K123141Enseal Trio Tissue Sealing DeviceEthicon Endo-Surgery, LLC20126—
+5K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC20260—
+5K252487POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)Gyrus Acmi, Inc.20260—
+5K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+5K241138ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing…Livsmed, Inc.20241—
+5K241635da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20241—
+5K231732CleanSeal Advanced Bipolar Vessel Sealer MarylandConmed Corporation20230—
+5K230650Monopolar Electrode Surgical InstrumentVhmed (Nantong) Co., Ltd.20230—
+5K230251Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability Solutions20230—
+5K223158LigaSure™ XP Maryland Jaw Sealer/DividerCovidien, LLC20231—
+5K2104788mm Monopolar Curved ScissorsIconocare Health20220—
+5K212614Ultrasonic Scalpel SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20221—
+5K220481Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)Stryker Sustainability Solutions20221—
+5K212891TempSure SystemCynosure, LLC20221—
+5K213354Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection…Conmed Corporation20220—
+5K211639BTL-785WBTL Industries, Inc.20227—
+5K202818Voyant Fine Fusion Device (EB230)Applied Medical20210—
+5K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+5K203682Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and…Olympus Winter & Ibe GmbH20212—
+5K202917LigaSure Exact Dissector, Nano-coatedCovidien, LLC20211—
+5K201696ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer…Ethicon Endo-Surgery, LLC20211—
+5K201066ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved…Ethicon Endo-Surgery, LLC20211—
+5K201212Voyant Open Fusion DeviceApplied Medical Resources Corp.20201—
+5K200841Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11Ethicon Endo-Surgery, LLC20204—
+5K200598Voyant Maryland Fusion DeviceApplied Medical Resources Corp.20201—
+5K182653Voyant Maryland Fusion DeviceApplied Medical Resources Corp.20185—
+5K182588Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/DividerSurgical Instrument Service and Savings Inc.(Dba Medline Ren201805
+5K181389Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy PlatformCovidien20185—
+5K173415EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc.20180—
+5K180403ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue…Ethicon Endo-Surgery, LLC20180—
+5K180699Voyant Open Fusion DeviceApplied Medical Resources Corporation20182—
+5K172580ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer…Ethicon Endo-Surgery, LLC201703
+5K172856Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/DividerStryker Sustainability Solutions20170—
+5K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc.20170—
+5K171066BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerCovidien, LLC20172—
+5K170908PK AIMGyrus Acmi, Inc.20170—
+5K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site…Intuitive Surgical, Inc.20178—
+5K163548ENSEAL X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20170—
+5K160333Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/DividerSurgical Instrument Service and Savings, Inc.201606
+5K153288Voyant Open Fusion DeviceApplied Medical Resources20160—
+6K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC20260—
+6K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions20260—
+6K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.20260—
+6K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+6K252740Voyant® Open Fusion Device (EB240/Open Fusion)Applied Medical Resources Corp.20250—
+6K250126ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Livsmed, Inc.20250—
+6K243067The ETHICON™ Total Energy SystemEthicon Endo-Surgery, LLC (A Johnson and Johnson Company)20250—
+6K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…Stryker Sustainability Solutions20240—
+6K233036Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd.20240—
+6K232511Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)Surgical Instrument Service and Savings, Inc.202401
+6K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…Stryker Sustainability Solutions20241—
+6K231327POWERSEAL Sealer and DividerGyrus Acmi, Inc.20230—
+6K222556BTL-785XBTL Industries, Inc.20235—
+6K230387ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue…Ethicon Endo-Surgery, LLC20230—
+6K230255Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019Stryker Sustainability Solutions20230—
+6K223292TempSure SystemCynosure, LLC20220—
+6K222284Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)Applied Medical Resources Corporation20220—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K212643POWERSEAL Curved Jaw Sealer and Divider, Double ActionOlympus Surgical Technologies America202117
+6K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device…Medtronic20182—
+6K182451BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerCovidien, LLC20181—
+6K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc.201871
+7K233849BTL-499BTL Industries, Inc.20240—
+7K233604BTL-785SBTL Industries, Inc.20243—
+7K193356BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerCovidien, LLC20200—
+7K191601Valleylab FT10 Electrosurgical PlatformCovidien201911
+7K183107Intuitive Surgical Vessel Sealer ExtendIntuitive Surgical, Inc.20186—
+8K253750BTL-785NEHBTL Industries, Inc.20260—
+8K250674Vessel Sealer Curved (480522)Intuitive Surgical, Inc.20250—
+8K242532BTL-785BNF-EBTL Industries, Inc.20241—
+8K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC20240—