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510(k) Data Aggregation

    K Number
    K250126
    Manufacturer
    Date Cleared
    2025-10-21

    (277 days)

    Product Code
    Regulation Number
    878.4400
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ArtiSeal Vessel Sealing System - ArtiSeal Instruments are a bipolar electrosurgical instrument intended for use only with the ArtiSeal Generator in minimally invasive or open surgical procedures where ligation (sealing) and division (Cutting) of vessels and tissue bundles is desired. ArtiSeal Vessel Sealing System - ArtiSeal Instruments can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery.

    Device Description

    The ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) is a sterile, single-use, invasive instrument which is used with electrosurgical generator (ArtiSeal 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 radiofrequency (RF) energy to the electrode portion of the jaw. Heat is generated from the electrode for ligation.

    During surgical procedures, the user operates the grip lever to open and close the jaw. Furthermore, the jaw can be bent up, down, left, and right within a range of up to ±90° or more by adjusting the grip accordingly. The jaw also provides 360° articulation (rotation) by turning the grip.

    AI/ML Overview

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