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

    Monotime and Optime R

    K Number: K233265 · Decision Oct 11, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    148
    Registration Numbers
    148
    Same Product Code
    142
    Applicant Total
    2
    Review Days
    378

    Basic Information

    Device Name
    Monotime and Optime R
    K Number
    K233265
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.4493
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Peters Surgical
    Date Received
    September 29, 2023
    Decision Date
    October 11, 2024
    Product Code
    GAM
    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
    GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

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