510(k) Report

Devices descending from K981916

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160331LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable…Covidien20160—
+1K160602JustRight Surgical Vessel Sealing SystemJustright Surgical20166—
+1K140459Altrus Thermal Tissue Fusion Energy Source, Altrus Thermal Tissue Fusion Handpiece…Conmed Corporation201401
+1K123662The Justright Surgical Vessel Sealing SystemJustright Surgical, LLC20137—
+1K110824Aragon Surgical RF System - 5MM Laparoscopic InstrumentAragon Surgical, Inc.20117—
+1K101534Conmed Altrus Thermal Tissue Fusion SystemConmedcorp201018
+1K090306Aragon Surgical RF System L2 InstrumentAragon Surgical, Inc.20099—
+1K081312Aragon Oneshot SystemAragon Surgical, Inc.200810—
+1K071759LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand…Live Tissue Connect, Inc.20080—
+1K060170Erbe Biclamp Open and Laparoscopic InstrumentsErbe USA, Inc.20060—
+1K051644Valleylab Forcetriad Electrosurgical GeneratorValleylab2005128—
+1K043273Ligasure Vessel Sealing System. Ligasure InstrumentsValleylab200537—
+1K033421Erbe Biclamp Open and Laparoscopic InstrumentsErbe USA, Inc.20042—
+1K024286Gyrus Open ForcepsGyrus Medical, Inc.2003146
+1K031133Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal Controller…Surgrx, Inc.200356—
+1K031011Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc.20031142
+2K203183CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)Bolder Surgical, LLC20212—
+2K203640CoolSeal RevealBolder Surgical, LLC20210—
+2K202114CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal…Bolder Surgical, LLC202041
+2K182365TempSure SystemCynosure, Inc.201815—
+2K171262TempSureCynosure, Inc.201716—
+2K142229Laparoscopic FMsealerDomain Surgical, Inc.20150—
+2K141484Open FmsealerDomain Surgical, Inc.201411
+2K130596Caiman Seal and Cut TechnologyAesculap, Inc.20136—
+2K123096Reprocessed Vessel SealerSterilmed, Inc.20131—
+2K111202Surgical Tissue Management SystemOlympus Medical Systems Corp.20121110
+2K110268Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison201116—
+2K102913ForcetriadCovidien, Formerly Valleylab, A Division of Tyco H20111—
+2K102470Lugasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab,201164—
+2K093075Aragon Surgical RF System Teleo InstrumentAragon Surgical, Inc.201072
+2K091259Ethicon Endo-Surgery Flexible Bipolar Hemostasis ForcepsEthicon Endo-Surgery, Inc.20100—
+2K092879Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerValleylab2009651
+2K082109Bovie Icon General Purpose RF GeneratorBovie Medical20081—
+2K081503Aed Monopolar Lap AccessoriesNational Advanced Endoscopy Devices, Inc.20087—
+2K081766PKS Omni InstrumentGyrus-Acmi L.P.200831
+2K081129Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD…Surgrx, Inc.200824—
+2K071728Modification to: Enseal PTC Tissue Sealing DeviceSurgrx, Inc.200716—
+2K062525Reprocessed Ligasure Vessel Sealer/DividerAscent Healthcare Solutions20070—
+2K070162Forcetriad Electrosurgical Generator; Ligasure InstrumentsValleylab,A Division of Tyco Healthcare Group LP2007102—
+2K063195Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models LF5034…Valleylab200631—
+2K061975Plasmaseal Open Forceps, Models 2103PK and 91701PKAcmi Corporation20064—
+2K061526Enseal PTC Tissue Sealing DeviceSurgrx, Inc.200653—
+2K050671Enseal Vessel Sealing & Hemostasis SystemSurgrx, Inc.200526—
+2K043008Surgrx Enseal Vessel Sealing & Hemostasis SystemSurgrx, Inc.200425—
+2K041587Ligasure Precise Model #LS1200/Ligasure 5MM Laparoscopic Sealer Divider Model # LS1500Valleylab200411—
+3K253634CoolSeal Generator® (CSL-200-90)Hologic, Inc.20260—
+3K223039da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20223—
+3K211579CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm…Bolder Surgical, LLC20211—
+3K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+3K203461Aesculap Caiman 12 Seal and Cut Technology SystemAesculap, Inc.20200—
+3K190678TempSureCynosure, Inc.201914—
+3K172691Ultrasonic GeneratorOlympus Medical Systems Corp.20174—
+3K161825PK AIMGyrus Acmi, Inc.20162—
+3K161804LigaSure Retractable L-Hook Laparoscopic Sealer/DividerCovidien20160—
+3K152219PK AIMGyrus Acmi, Inc.20153—
+3K150835LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol GripCovidien20151—
+3K151649Valleylab FT10 Electrosurgical PlatformCovidien201510—
+3K152286LigaSure Curved, Small Jaw, Open Sealer/DividerCovidien201514—
+3K151696Caiman Seal and Cut TechnologyAesculap, Inc.20152—
+3K143536Voyant Fine Fusion DeviceApplied Medical Resources20152—
+3K143654Valleylab LS10 GeneratorCovidien, LLC20150—
+3K143260Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/DividerSterilmed, Inc.20150—
+3K141288Voyant Electrosurgical Generator, Voyant 5MM Laparoscopic Sealer-Divider DeviceApplied Medical Resources20149—
+3K132703ThunderbeatOlympus Medical Systems Corp.20149—
+3K140839Caiman Seal and Cut TechnologyAesculap, Inc.20141—
+3K133338Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)Covidien, Formerly Valleylab, A Division of Tyco H201343—
+3K130266Endowrist One Vessel SealerIntuitive Surgical, Inc.2013101
+3K130744Ligasure 5MM Blunt Tip Laparoscopic Sealer/DividerCovidien201342—
+3K123444Ligasure Impact Curved, Large Jaw, Open Sealer / DividerCovidien, Formerly Valleylab, A Division of Tyco H201356—
+3K120040Reprocessed Surgical Electric InstrumentSterilmed, Inc.20120—
+3K113572Ligasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, A Division of Tyco H201262—
+3K110639Endowrist One Vessel SealerIntuitive Surgical, Inc.2011152
+3K103508Unmiax Laparoscopic InstrumentUnimax Medical Systems, Inc.20116—
+3K111600Reprocessed Hand Activate Sealer/DividerAscent Healthcare Solutions20110—
+3K110695Bipolar HF DeviceAesculap, Inc.20110—
+3K101990Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC201111—
+3K092383Bovie Icon VS General Purpose RF Generator, Model: VS300Bovie Medical Corporation20100—
+3K070896Enseal PTC Tissue Sealing DeviceSurgrx, Inc.2007321
+3K070165Enseal PTC TrioSurgrx, Inc.2007251
+3K062949Enseal PTC Tissue Seating Sealing DeviceSurgrx, Inc.200626—
+3K063097Enseal PTC Tissue Sealing DeviceSurgrx, Inc.200634—
+4K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+4K252412Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)Applied Medical Resources Corporation20250—
+4K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+4K242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic…Shanghai Saints Sages Surgical Co., Ltd.20250—
+4K230621LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic ProbesSurgical Principals, Inc.20230—
+4K231012CoolSeal TrinityBolder Surgical, LLC20230—
+4K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+4K231212da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20232—
+4K220411Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability Solutions20221—
+4K202938Aesculap Caiman 5 Seal and Cut Technology SystemAesculap, Inc.20200—
+4K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+4K200241TempSure SystemCynosure, LLC202013—
+4K193292Voyant 5mm Fusion Device, Voyant Maryland Fusion DeviceApplied Medical Resources Corp.20194—
+4K192235AEON Laparoscopic InstrumentsLexington Medical, Inc.20190—
+4K183180Caiman 5 MarylandAesculap, Inc.201901
+4K182244Voyant Electrosurgical GeneratorApplied Medical Resources Corp.20181—
+4K180575THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.20180—
+4K181085LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coatedCovidien20181—
+4K180499Reprocessed LigaSure Maryland Jaw Sealer/DividerStryker Sustainability Solutions20180—