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

    QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN

    K Number: K141778 · Decision Jul 30, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    147
    Applicant Total
    2
    Review Days
    28

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    Basic Information

    Device Name
    QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
    K Number
    K141778
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4493
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Specialties Corporation
    Date Received
    July 2, 2014
    Decision Date
    July 30, 2014
    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 Surgical Specialties Corporation

    K Number Device Name
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