BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    MENIX®; MENIX® DUO

    K Number: K223122 · Decision Aug 3, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    242
    Registration Numbers
    242
    Same Product Code
    173
    Applicant Total
    2
    Review Days
    304

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    Basic Information

    Device Name
    MENIX®; MENIX® DUO
    K Number
    K223122
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5000
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    S.B.M. Sas (Science & Bio Materials)
    Date Received
    October 3, 2022
    Decision Date
    August 3, 2023
    Product Code
    GAT
    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
    GAT Suture, Nonabsorbable, Synthetic, Polyethylene

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    Other Clearances by S.B.M. Sas (Science & Bio Materials)

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