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

    QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE

    K Number: K113800 · Decision Jan 20, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    84
    Applicant Total
    7
    Review Days
    28

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    Basic Information

    Device Name
    QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE
    K Number
    K113800
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.5010
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Angiotech
    Date Received
    December 23, 2011
    Decision Date
    January 20, 2012
    Product Code
    GAW
    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
    GAW Suture, Nonabsorbable, Synthetic, Polypropylene

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