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

    StitchKit COMBO

    K Number: K202950 · Decision Feb 23, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    147
    Applicant Total
    2
    Review Days
    146

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    Basic Information

    Device Name
    StitchKit COMBO
    K Number
    K202950
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4493
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Origami Surgical
    Date Received
    September 30, 2020
    Decision Date
    February 23, 2021
    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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    Other Clearances by Origami Surgical

    K Number Device Name
    K191317 StitchKit