510(k) Report

Devices descending from K946177

203 later devices reach Valleylab NS 2000 Bipolar Generator System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K180499Reprocessed LigaSure Maryland Jaw Sealer/DividerStryker Sustainability Solutions20180—
+5K172610THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.201843
+5K173281LigaSure Exact Dissector, Nano-coatedCovidien20185—
+5K172624Voyant 5mm Fusion DeviceApplied Medical Resources Corporation20186—
+5K172757Valleylab FX8 Electrosurgical PlatformCovidien, LLC20176—
+5K162751Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/DividerSurgical Instrument Services and Savings, Inc.201701
+5K170869LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coatedCovidien201711—
+5K170170Valleylab FT10 Electrosurgical PlatformCovidien, LLC20178—
+5K163373PK AIMGyrus Acmi, Inc.20161—
+5K162676Voyant Open Fusion DeviceApplied Medical Resources20163—
+5K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien201641
+5K162047LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coatedCovidien20163—
+5K160554Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20166—
+5K153017Voyant Fine FusionApplied Medical Resources20161—
+5K160539BiZact Open Sealer/DividerCovidien20163—
+5K153745Medline ReNewal Reprocessed LigaSure Impact Open Sealer/DividerSurgical Instrument Service and Savings Inc.(Dba Medline Ren201604
+5K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+5K152134Reprocessed Vessel SealerSterilmed, Inc.20160—
+5K151858Caiman Seal and Cut TechnologyAesculap, Inc.201501
+5K150538Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/DividerStryker Sustainability Solutions20150—
+5K142208Monopolar Laparascopic AccessoriesUnimicro Medical Systems (Shenzhen) Co., Ltd.20151—
+5K143517Voyant Open Sealer-Divider DeviceApplied Medical Resources201511
+5K142929Ligasure Blunt Tip Sealer/DividerCovidien20156—
+5K1428685mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm…Purple Surgical International Limited20140—
+5K123329DA Vinvi Surgical SystemIntuitive Surgical, Inc.20143—
+5K141122Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC20149—
+5K141153Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw…Covidien201440—
+5K140189Endowrist Vessel SealerIntuitive Surgical, Inc.201491
+5K131435Enseal G2 Tissue Sealer, Straight Jaw, Enseal G2 Tissue Sealer, Curved Jaw, Enseal Trio…Ethicon Endo-Surgery, LLC20135—
+5K123260Detachatip IiiConmed Corporation20120—
+5K123141Enseal Trio Tissue Sealing DeviceEthicon Endo-Surgery, LLC20126—
+6K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC20260—
+6K252487POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)Gyrus Acmi, Inc.20260—
+6K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+6K241138ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing…Livsmed, Inc.20241—
+6K241635da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20241—
+6K231732CleanSeal Advanced Bipolar Vessel Sealer MarylandConmed Corporation20230—
+6K230650Monopolar Electrode Surgical InstrumentVhmed (Nantong) Co., Ltd.20230—
+6K230251Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability Solutions20230—
+6K223158LigaSure™ XP Maryland Jaw Sealer/DividerCovidien, LLC20231—
+6K2104788mm Monopolar Curved ScissorsIconocare Health20220—
+6K212614Ultrasonic Scalpel SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20221—
+6K220481Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)Stryker Sustainability Solutions20221—
+6K212891TempSure SystemCynosure, LLC20221—
+6K213354Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection…Conmed Corporation20220—
+6K211639BTL-785WBTL Industries, Inc.20227—
+6K202818Voyant Fine Fusion Device (EB230)Applied Medical20210—
+6K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+6K203682Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and…Olympus Winter & Ibe GmbH20212—
+6K202917LigaSure Exact Dissector, Nano-coatedCovidien, LLC20211—
+6K201696ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer…Ethicon Endo-Surgery, LLC20211—
+6K201066ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved…Ethicon Endo-Surgery, LLC20211—
+6K201212Voyant Open Fusion DeviceApplied Medical Resources Corp.20201—
+6K200841Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11Ethicon Endo-Surgery, LLC20204—
+6K200598Voyant Maryland Fusion DeviceApplied Medical Resources Corp.20201—
+6K182653Voyant Maryland Fusion DeviceApplied Medical Resources Corp.20185—
+6K182588Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/DividerSurgical Instrument Service and Savings Inc.(Dba Medline Ren201805
+6K181389Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy PlatformCovidien20185—
+6K173415EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc.20180—
+6K180403ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue…Ethicon Endo-Surgery, LLC20180—
+6K180699Voyant Open Fusion DeviceApplied Medical Resources Corporation20182—
+6K172580ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer…Ethicon Endo-Surgery, LLC201703
+6K172856Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/DividerStryker Sustainability Solutions20170—
+6K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc.20170—
+6K171066BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerCovidien, LLC20172—
+6K170908PK AIMGyrus Acmi, Inc.20170—
+6K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site…Intuitive Surgical, Inc.20178—
+6K163548ENSEAL X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20170—
+6K160333Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/DividerSurgical Instrument Service and Savings, Inc.201606
+6K153288Voyant Open Fusion DeviceApplied Medical Resources20160—
+7K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC20260—
+7K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions20260—
+7K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.20260—
+7K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+7K252740Voyant® Open Fusion Device (EB240/Open Fusion)Applied Medical Resources Corp.20250—
+7K250126ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Livsmed, Inc.20250—
+7K243067The ETHICON™ Total Energy SystemEthicon Endo-Surgery, LLC (A Johnson and Johnson Company)20250—
+7K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…Stryker Sustainability Solutions20240—
+7K233036Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd.20240—
+7K232511Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)Surgical Instrument Service and Savings, Inc.202401
+7K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…Stryker Sustainability Solutions20241—
+7K231327POWERSEAL Sealer and DividerGyrus Acmi, Inc.20230—
+7K222556BTL-785XBTL Industries, Inc.20235—
+7K230387ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue…Ethicon Endo-Surgery, LLC20230—
+7K230255Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019Stryker Sustainability Solutions20230—
+7K223292TempSure SystemCynosure, LLC20220—
+7K222284Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)Applied Medical Resources Corporation20220—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K212643POWERSEAL Curved Jaw Sealer and Divider, Double ActionOlympus Surgical Technologies America202117
+7K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device…Medtronic20182—
+7K182451BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerCovidien, LLC20181—
+7K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc.201871
+8K233849BTL-499BTL Industries, Inc.20240—
+8K233604BTL-785SBTL Industries, Inc.20243—
+8K193356BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerCovidien, LLC20200—
+8K191601Valleylab FT10 Electrosurgical PlatformCovidien201911
+8K183107Intuitive Surgical Vessel Sealer ExtendIntuitive Surgical, Inc.20186—
+9K253750BTL-785NEHBTL Industries, Inc.20260—
+9K250674Vessel Sealer Curved (480522)Intuitive Surgical, Inc.20250—
+9K242532BTL-785BNF-EBTL Industries, Inc.20241—