510(k) Report

Devices descending from K010013

122 later devices reach Ligasure Laparoscopic Sealer Divider Model LS1100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123444Ligasure Impact Curved, Large Jaw, Open Sealer / DividerCovidien, Formerly Valleylab, A Division of Tyco H201356—
+1K090306Aragon Surgical RF System L2 InstrumentAragon Surgical, Inc.20099—
+1K031011Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc.20031142
+2K162676Voyant Open Fusion DeviceApplied Medical Resources20163—
+2K162047LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coatedCovidien20163—
+2K160554Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20166—
+2K153745Medline ReNewal Reprocessed LigaSure Impact Open Sealer/DividerSurgical Instrument Service and Savings Inc.(Dba Medline Ren201604
+2K150538Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/DividerStryker Sustainability Solutions20150—
+2K143517Voyant Open Sealer-Divider DeviceApplied Medical Resources201511
+2K141153Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw…Covidien201440—
+2K130596Caiman Seal and Cut TechnologyAesculap, Inc.20136—
+2K123096Reprocessed Vessel SealerSterilmed, Inc.20131—
+2K111202Surgical Tissue Management SystemOlympus Medical Systems Corp.20121110
+2K110824Aragon Surgical RF System - 5MM Laparoscopic InstrumentAragon Surgical, Inc.20117—
+2K102470Lugasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab,201164—
+2K093075Aragon Surgical RF System Teleo InstrumentAragon Surgical, Inc.201072
+2K092879Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerValleylab2009651
+2K081766PKS Omni InstrumentGyrus-Acmi L.P.200831
+2K062525Reprocessed Ligasure Vessel Sealer/DividerAscent Healthcare Solutions20070—
+2K063195Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models LF5034…Valleylab200631—
+2K041587Ligasure Precise Model #LS1200/Ligasure 5MM Laparoscopic Sealer Divider Model # LS1500Valleylab200411—
+3K252487POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)Gyrus Acmi, Inc.20260—
+3K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+3K203682Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and…Olympus Winter & Ibe GmbH20212—
+3K203461Aesculap Caiman 12 Seal and Cut Technology SystemAesculap, Inc.20200—
+3K200841Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11Ethicon Endo-Surgery, LLC20204—
+3K182588Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/DividerSurgical Instrument Service and Savings Inc.(Dba Medline Ren201805
+3K181085LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coatedCovidien20181—
+3K180699Voyant Open Fusion DeviceApplied Medical Resources Corporation20182—
+3K172856Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/DividerStryker Sustainability Solutions20170—
+3K172691Ultrasonic GeneratorOlympus Medical Systems Corp.20174—
+3K170869LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coatedCovidien201711—
+3K163548ENSEAL X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20170—
+3K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien201641
+3K161825PK AIMGyrus Acmi, Inc.20162—
+3K161804LigaSure Retractable L-Hook Laparoscopic Sealer/DividerCovidien20160—
+3K160331LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable…Covidien20160—
+3K153288Voyant Open Fusion DeviceApplied Medical Resources20160—
+3K152219PK AIMGyrus Acmi, Inc.20153—
+3K150835LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol GripCovidien20151—
+3K152286LigaSure Curved, Small Jaw, Open Sealer/DividerCovidien201514—
+3K151696Caiman Seal and Cut TechnologyAesculap, Inc.20152—
+3K143536Voyant Fine Fusion DeviceApplied Medical Resources20152—
+3K143260Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/DividerSterilmed, Inc.20150—
+3K142929Ligasure Blunt Tip Sealer/DividerCovidien20156—
+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—
+3K130744Ligasure 5MM Blunt Tip Laparoscopic Sealer/DividerCovidien201342—
+3K113572Ligasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, A Division of Tyco H201262—
+3K081312Aragon Oneshot SystemAragon Surgical, Inc.200810—
+3K071759LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand…Live Tissue Connect, Inc.20080—
+3K081129Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD…Surgrx, Inc.200824—
+4K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC20260—
+4K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC20260—
+4K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+4K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+4K243067The ETHICON™ Total Energy SystemEthicon Endo-Surgery, LLC (A Johnson and Johnson Company)20250—
+4K241138ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing…Livsmed, Inc.20241—
+4K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…Stryker Sustainability Solutions20240—
+4K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…Stryker Sustainability Solutions20241—
+4K231327POWERSEAL Sealer and DividerGyrus Acmi, Inc.20230—
+4K231732CleanSeal Advanced Bipolar Vessel Sealer MarylandConmed Corporation20230—
+4K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+4K223158LigaSure™ XP Maryland Jaw Sealer/DividerCovidien, LLC20231—
+4K220411Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability Solutions20221—
+4K213354Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection…Conmed Corporation20220—
+4K212643POWERSEAL Curved Jaw Sealer and Divider, Double ActionOlympus Surgical Technologies America202117
+4K211579CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm…Bolder Surgical, LLC20211—
+4K202938Aesculap Caiman 5 Seal and Cut Technology SystemAesculap, Inc.20200—
+4K202114CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal…Bolder Surgical, LLC202041
+4K201212Voyant Open Fusion DeviceApplied Medical Resources Corp.20201—
+4K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+4K193292Voyant 5mm Fusion Device, Voyant Maryland Fusion DeviceApplied Medical Resources Corp.20194—
+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—
+4K180499Reprocessed LigaSure Maryland Jaw Sealer/DividerStryker Sustainability Solutions20180—
+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—
+4K162751Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/DividerSurgical Instrument Services and Savings, Inc.201701
+4K163373PK AIMGyrus Acmi, Inc.20161—
+4K160333Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/DividerSurgical Instrument Service and Savings, Inc.201606
+4K153017Voyant Fine FusionApplied Medical Resources20161—
+4K160539BiZact Open Sealer/DividerCovidien20163—
+4K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+4K152134Reprocessed Vessel SealerSterilmed, Inc.20160—
+4K151858Caiman Seal and Cut TechnologyAesculap, Inc.201501
+4K131435Enseal G2 Tissue Sealer, Straight Jaw, Enseal G2 Tissue Sealer, Curved Jaw, Enseal Trio…Ethicon Endo-Surgery, LLC20135—
+4K101990Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC201111—
+5K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions20260—
+5K253634CoolSeal Generator® (CSL-200-90)Hologic, Inc.20260—
+5K252740Voyant® Open Fusion Device (EB240/Open Fusion)Applied Medical Resources Corp.20250—
+5K252412Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)Applied Medical Resources Corporation20250—
+5K250126ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Livsmed, Inc.20250—
+5K242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic…Shanghai Saints Sages Surgical Co., Ltd.20250—
+5K231012CoolSeal TrinityBolder Surgical, LLC20230—
+5K230251Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability Solutions20230—