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

    QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)

    K Number: K120827 · Decision Jul 13, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    63
    Applicant Total
    7
    Review Days
    116

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    Basic Information

    Device Name
    QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)
    K Number
    K120827
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4840
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Angiotech
    Date Received
    March 19, 2012
    Decision Date
    July 13, 2012
    Product Code
    NEW
    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
    NEW Suture, Surgical, Absorbable, Polydioxanone

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