BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Jewel Soft Tissue Reinforcement Device (102-6005)

    K Number: K242237 · Decision Jul 15, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    350

    Basic Information

    Device Name
    Jewel Soft Tissue Reinforcement Device (102-6005)
    K Number
    K242237
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xiros Limited
    Date Received
    July 30, 2024
    Decision Date
    July 15, 2025
    Product Code
    QUW
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QUW Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament

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