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510(k) Data Aggregation

    K Number
    K230089
    Device Name
    ETHICON LINX® Esophagus Sizing Tool
    Manufacturer
    Torax Medical Inc.
    Date Cleared
    2023-02-09

    (28 days)

    Product Code
    QJN
    Regulation Number
    876.5360
    Why did this record match?
    Applicant Name (Manufacturer) :

    Torax Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ETHICON LINX® Esophagus Sizing Tool for the LINX Reflux Management System is a laparoscopic accessory used to estimate the appropriate size LINX® device.
    Device Description
    The LINX Esophagus Sizing Tool is a sterile, single-use device that is used as an accessory to the LINX Reflux Management System (packaged separately). The device has a soft, circular curved tip that is actuated by coaxial tubes via a handset. The handset contains numerical indicators that correspond to the size range of the LINX implant.
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