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510(k) Data Aggregation

    K Number
    K233322
    Device Name
    Mochida Nerve Cuff
    Manufacturer
    Mochida Pharmaceutical Co., Ltd.
    Date Cleared
    2024-06-21

    (266 days)

    Product Code
    JXI
    Regulation Number
    882.5275
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mochida Pharmaceutical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mochida Nerve Cuff is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity, or the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
    Device Description
    The Mochida Nerve Cuff is made from a polyglycolic acid (PGA) sheet embedded into covalently cross-linked alginate gel, which is produced into a sponge form by freeze-drying and pressing into sheets. The device is designed to repair peripheral nerve function by supporting the extension of the axon by providing a scaffold for growth of axons and Schwann cells following the degradation/absorption process after nerve injury. The device is to be implanted to cover the damaged, severed or excised section of the nerve axons. When used, the device is cut according to the size of the nerve axon injury site, and fixed in place to cover the site.
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