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

    Voyant® Open Fusion Device (EB240/Open Fusion)

    K Number: K252740 · Decision Nov 4, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    45
    Review Days
    68

    Basic Information

    Device Name
    Voyant® Open Fusion Device (EB240/Open Fusion)
    K Number
    K252740
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Applied Medical Resources Corp.
    Date Received
    August 28, 2025
    Decision Date
    November 4, 2025
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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