510(k) Report

Devices descending from K123444

56 later devices reach Ligasure Impact Curved, Large Jaw, Open Sealer / Divider through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162676Voyant Open Fusion DeviceApplied Medical Resources20163—
+1K162047LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coatedCovidien20163—
+1K160554Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20166—
+1K153745Medline ReNewal Reprocessed LigaSure Impact Open Sealer/DividerSurgical Instrument Service and Savings Inc.(Dba Medline Ren201604
+1K150538Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/DividerStryker Sustainability Solutions20150—
+1K143517Voyant Open Sealer-Divider DeviceApplied Medical Resources201511
+1K141153Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw…Covidien201440—
+2K252487POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)Gyrus Acmi, Inc.20260—
+2K203682Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and…Olympus Winter & Ibe GmbH20212—
+2K200841Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11Ethicon Endo-Surgery, LLC20204—
+2K182588Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/DividerSurgical Instrument Service and Savings Inc.(Dba Medline Ren201805
+2K181085LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coatedCovidien20181—
+2K180699Voyant Open Fusion DeviceApplied Medical Resources Corporation20182—
+2K172856Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/DividerStryker Sustainability Solutions20170—
+2K170869LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coatedCovidien201711—
+2K163548ENSEAL X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20170—
+2K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien201641
+2K161804LigaSure Retractable L-Hook Laparoscopic Sealer/DividerCovidien20160—
+2K160331LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable…Covidien20160—
+2K153288Voyant Open Fusion DeviceApplied Medical Resources20160—
+2K152286LigaSure Curved, Small Jaw, Open Sealer/DividerCovidien201514—
+2K142929Ligasure Blunt Tip Sealer/DividerCovidien20156—
+3K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC20260—
+3K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC20260—
+3K243067The ETHICON™ Total Energy SystemEthicon Endo-Surgery, LLC (A Johnson and Johnson Company)20250—
+3K241138ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing…Livsmed, Inc.20241—
+3K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…Stryker Sustainability Solutions20240—
+3K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…Stryker Sustainability Solutions20241—
+3K231327POWERSEAL Sealer and DividerGyrus Acmi, Inc.20230—
+3K231732CleanSeal Advanced Bipolar Vessel Sealer MarylandConmed Corporation20230—
+3K223158LigaSure™ XP Maryland Jaw Sealer/DividerCovidien, LLC20231—
+3K220411Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability Solutions20221—
+3K213354Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection…Conmed Corporation20220—
+3K212643POWERSEAL Curved Jaw Sealer and Divider, Double ActionOlympus Surgical Technologies America202117
+3K211579CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm…Bolder Surgical, LLC20211—
+3K202114CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal…Bolder Surgical, LLC202041
+3K201212Voyant Open Fusion DeviceApplied Medical Resources Corp.20201—
+3K173281LigaSure Exact Dissector, Nano-coatedCovidien20185—
+3K162751Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/DividerSurgical Instrument Services and Savings, Inc.201701
+3K160333Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/DividerSurgical Instrument Service and Savings, Inc.201606
+3K160539BiZact Open Sealer/DividerCovidien20163—
+4K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions20260—
+4K253634CoolSeal Generator® (CSL-200-90)Hologic, Inc.20260—
+4K252740Voyant® Open Fusion Device (EB240/Open Fusion)Applied Medical Resources Corp.20250—
+4K250126ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Livsmed, Inc.20250—
+4K231012CoolSeal TrinityBolder Surgical, LLC20230—
+4K230251Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability Solutions20230—
+4K220481Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)Stryker Sustainability Solutions20221—
+4K203640CoolSeal RevealBolder Surgical, LLC20210—
+4K203183CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)Bolder Surgical, LLC20212—
+4K202917LigaSure Exact Dissector, Nano-coatedCovidien, LLC20211—
+4K171066BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerCovidien, LLC20172—
+5K232511Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)Surgical Instrument Service and Savings, Inc.202401
+5K230255Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019Stryker Sustainability Solutions20230—
+5K182451BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerCovidien, LLC20181—
+6K193356BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerCovidien, LLC20200—