510(k) Report

Devices descending from K112033

76 later devices reach Enseal G2 Tissus Sealers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201696ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer…Ethicon Endo-Surgery, LLC20211—
+1K180403ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue…Ethicon Endo-Surgery, LLC20180—
+1K172580ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer…Ethicon Endo-Surgery, LLC201703
+1K132612Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic Ace + Laparoscopic…Ethicon Endo-Surgery, LLC2013161
+1K131435Enseal G2 Tissue Sealer, Straight Jaw, Enseal G2 Tissue Sealer, Curved Jaw, Enseal Trio…Ethicon Endo-Surgery, LLC20135—
+1K123444Ligasure Impact Curved, Large Jaw, Open Sealer / DividerCovidien, Formerly Valleylab, A Division of Tyco H201356—
+1K122797Enseal G2 Articulating Tissue Sealers, Straight Jaw, Enseal G2 Articulating Tissue…Ethicon Endo-Surgery, LLC20130—
+2K242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic…Shanghai Saints Sages Surgical Co., Ltd.20250—
+2K230387ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue…Ethicon Endo-Surgery, LLC20230—
+2K221790HARMONIC 700 ShearsEthicon Endo-Surgery, LLC20231—
+2K212614Ultrasonic Scalpel SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20221—
+2K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+2K202554Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced HemostasisStryker Sustainability Solutions20211—
+2K201066ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved…Ethicon Endo-Surgery, LLC20211—
+2K193563Medline ReNewal Reprocessed Harmonic ACE+7 ShearsSurgical Instrument Service and Savings Inc.(Dba Medline Ren202002
+2K161693Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced HemostasisStryker Sustainability Solutions201702
+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—
+2K160752HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm LengthEthicon Endo-Suregery, 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—
+3K252487POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)Gyrus Acmi, Inc.20260—
+3K250898Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears…Stryker Sustainability Solutions20250—
+3K233036Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd.20240—
+3K203682Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and…Olympus Winter & Ibe GmbH20212—
+3K200841Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11Ethicon Endo-Surgery, LLC20204—
+3K191555HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm lengthEthicon Endo-Surgery, LLC202052
+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—
+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
+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—
+3K152286LigaSure Curved, Small Jaw, Open Sealer/DividerCovidien201514—
+3K142929Ligasure Blunt Tip Sealer/DividerCovidien20156—
+4K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC20260—
+4K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC20260—
+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—
+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—
+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—
+4K173281LigaSure Exact Dissector, Nano-coatedCovidien20185—
+4K162751Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/DividerSurgical Instrument Services and Savings, Inc.201701
+4K160333Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/DividerSurgical Instrument Service and Savings, Inc.201606
+4K160539BiZact Open Sealer/DividerCovidien20163—
+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—
+5K250126ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Livsmed, Inc.20250—
+5K231012CoolSeal TrinityBolder Surgical, LLC20230—
+5K230251Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability Solutions20230—
+5K220481Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)Stryker Sustainability Solutions20221—
+5K203640CoolSeal RevealBolder Surgical, LLC20210—
+5K203183CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)Bolder Surgical, LLC20212—
+5K202917LigaSure Exact Dissector, Nano-coatedCovidien, LLC20211—
+5K171066BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerCovidien, LLC20172—
+6K232511Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)Surgical Instrument Service and Savings, Inc.202401
+6K230255Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019Stryker Sustainability Solutions20230—
+6K182451BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerCovidien, LLC20181—
+7K193356BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerCovidien, LLC20200—