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510(k) Data Aggregation

    K Number
    K241138
    Device Name
    ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator
    Manufacturer
    LivsMed Inc.
    Date Cleared
    2024-11-15

    (205 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    LivsMed Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ArtiSeal Vessel Sealing System-ArtiSeal Instruments are a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation (Cutting) of vessels and tissue bundles is desired. ArtiSeal Vessel Sealing System - ArtiSeal Instruments can be used on veins) up to and including 7 mm. It is indicated for use in general surgery. The ArtiSeal Vessel Sealing System - ArtiSeal Generator is a high-frequency electrosurgical device used in conjunction with disposable hand-controlled electrosurgical instruments, known as ArtiSeal Instruments. It provides radiofrequency (RF) energy to ligate vessels and tissue bundles. This energy platform automatically detects the connected instrument and immediately performs safety and diagnostic functions for the instrument. It is indicated for use in general surgery.
    Device Description
    ArtiSeal Vessel Sealing System - ArtiSeal Instruments The ArtiSeal Vessel Sealing System - ArtiSeal invasive invasive instruments which are used with electrosurgical generator), intended to be used during laparoscopic/minimally invasive or open surgical procedures where ligation and division of vessels and tissue bundles is desired. When activating the sealing button of ArtiSeal Vessel Sealing System-ArtiSeal instruments, the ArtiSeal Generator applies a high frequency (RF) energy to the electrode portion of the jaw. Heat is generated from the electrode for ligation. During a procedure with this product, the jaw opens, and jaw closes if the grip lever pulled. In addition, the jaw is also bent up, down, left, and right within a range of ±80° or more by moving the grip up, down, left, and tight, and the jaw can also turn 360° when rotating the grip. ArtiSeal Vessel Sealing System - ArtiSeal Generator The ArtiSeal Vessel Sealing System - ArtiSeal Generator supplies RF energy to the ArtiSeal Instruments. This energy supply device uses a touchscreen interface and features a unique instrument connecting the ArtiSeal Instrument. By connecting the connector on the ArtiSeal Instrument connection socket, the energy supply device can provide energy to the electrode.
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    K Number
    K240657
    Device Name
    ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-
    Manufacturer
    LivsMed Inc.
    Date Cleared
    2024-06-06

    (90 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    LivsMed Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series (Hand-controlled) are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.
    Device Description
    It uses the principle of applying high-frequency currents from the electrode to the human body to generate heat by bioimpedance when radio frequency (RF) energy from the electrosurgical unit applies an electric current to the electrode part, and using the generated heat to incise cellular tissues and cause coagulation. It is composed of a end-tip, Φ5, Φ8 diameter shaft, grip part, and electrosurgical unit connection electrode plug.
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    K Number
    K230498
    Device Name
    ArtiSential Laparoscopic Instruments-Electrodes
    Manufacturer
    LivsMed Inc.
    Date Cleared
    2023-06-05

    (101 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    LivsMed Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.
    Device Description
    This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two Version, one for Hook and Spatula. The two models are same except for jaw. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.
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    K Number
    K230539
    Device Name
    ArtiSential Laparoscopic Instruments-Electrodes
    Manufacturer
    LivsMed Inc.
    Date Cleared
    2023-04-27

    (59 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    LivsMed Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.
    Device Description
    This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two Version, one for Dissector and Scissors. The two models are same except for jaw. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.
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    K Number
    K230499
    Device Name
    ArtiSential Laparoscopic Instruments-Electrodes
    Manufacturer
    LivsMed Inc.
    Date Cleared
    2023-04-26

    (61 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    LivsMed Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.
    Device Description
    The ArtiSential Laparoscopic Instruments – Electrodes, Bipolar series(four versions, ABF01 series, ABD01 series, ABD02 series and ABD04 series) are sterile, single-use, invasive instruments that used in laparoscopic surgery. There are four versions, ABF01 series, ABD01 series, ABD02 series and ABD04 series. Three versions are same except for jaw shape. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.
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    K Number
    K220384
    Device Name
    ArtiSential Laparoscopic Instruments-Electrodes
    Manufacturer
    LivsMed Inc.
    Date Cleared
    2022-02-24

    (14 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    LivsMed Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.
    Device Description
    The ArtiSential Laparoscopic Instruments - Electrodes, Bipolar series are sterile, single-use, invasive instruments that used in laparoscopic surgery. There are three versions, ABF01 series and ABD02 series. Three versions are same except for jaw shape. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.
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    K Number
    K212500
    Device Name
    ArtiSential Trocar
    Manufacturer
    LivsMed Inc.
    Date Cleared
    2021-12-03

    (116 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    LivsMed Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ArtiSential Trocar has an application in general, abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.
    Device Description
    ArtiSential Trocar is for use during endoscopic minimally invasive procedures or to gain access potential spaces for endoscopic instruments. This device is a sterile, single-use instruments consisting of a main body, cannula, obturator. An optical element, which when used with an endoscope, provides visibility of individual tissue layers during insertion. And a funnel serves as an instrument insertion guide and aids in the insertion of a passive multijoint surgical instrument into the cannula.
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    K Number
    K203580
    Device Name
    ArtiSential Laparoscopic Instruments-Electrodes
    Manufacturer
    LivsMed Inc.
    Date Cleared
    2021-04-30

    (144 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    LivsMed Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.
    Device Description
    This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two Version, one for Dissector and Scissors. The two models are same except for jaw. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.
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    K Number
    K200875
    Device Name
    ArtiSential Laparoscopic Instruments - Electrodes
    Manufacturer
    LivsMed Inc.
    Date Cleared
    2020-06-17

    (77 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    LivsMed Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.
    Device Description
    The ArtiSential Laparoscopic Instruments - Electrodes, Bipolar series are sterile, single-use, invasive instruments that used in laparoscopic surgery. There are three versions, ABF01 series, and ABD02 series. Three versions are same except for jaw shape. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.
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    K Number
    K200501
    Device Name
    ArtiSential Laparoscopic Instrument-Electrodes
    Manufacturer
    LivsMed Inc.
    Date Cleared
    2020-05-11

    (73 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    LivsMed Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.
    Device Description
    This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two Version, one for Hook and Spatula. The two models are same except for jaw. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.
    Ask a Question

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