BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Oxiplex

    K Number: K253326 · Decision May 1, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    213

    Basic Information

    Device Name
    Oxiplex
    K Number
    K253326
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3047
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fziomed, Inc.
    Date Received
    September 30, 2025
    Decision Date
    May 1, 2026
    Product Code
    QVL
    Advisory Committee
    Orthopedic
    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
    QVL Absorbable Gel For Intraoperative Use In Spine Surgery

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QVL), ordered by most recent decision date.

    Oxiplex®

    FDA 510(k)
    FDA Class 2 ·Orthopedic
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    Other Clearances by Fziomed, Inc.

    K Number Device Name
    DEN240038 Oxiplex®