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510(k) Data Aggregation

    K Number
    K201035
    Device Name
    ETHICON Linx Esophagus Sizing Tool
    Date Cleared
    2020-07-09

    (80 days)

    Product Code
    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 ETHICON Linx Esophagus Sizing Tool (also referred to as LINX® Esophagus Sizing Tool, hereafter) is an accessory to the LINX Reflux Management System implant (packaged separately). The LINX Esophagus Sizing Tool is a single use disposable device that is provided sterile. The LINX Esophagus Sizing Tool is a laparoscopic instrument and has two ends – the handset, considered the proximal end and not intended for patient contact, and the shaft with protruding circular curved tip, considered the distal end and is intended for limited contact with the patient. The handset is designed with a thumbwheel for one-handed operation. When actuated, the thumbwheel advances and retracts the soft polymeric circular curved tip of the distal end. The handle has a numerical indicator which directly correlates with the number of beads for the range of sizes of the approved LINX implant device. The shaft and distal end of the circular curved tip each have a magnet which allows the user to create a loop and attach the magnets to each other. Once the magnets are attached, the user retracts slack from the soft distal end until the loop is in circumferential contact with the esophagus. The LINX Esophagus Sizing Tool is utilized at the time of implant to associate the esophagus size to a LINX implant device size to aid in guiding the user into choosing an appropriately sized LINX implant device.
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