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

    Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)

    K Number: K222284 · Decision Oct 14, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    12
    Review Days
    74

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    Basic Information

    Device Name
    Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)
    K Number
    K222284
    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 Corporation
    Date Received
    August 1, 2022
    Decision Date
    October 14, 2022
    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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