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

    SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE

    K Number: K032468 · Decision Sep 23, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    31
    Applicant Total
    4
    Review Days
    43

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    Basic Information

    Device Name
    SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE
    K Number
    K032468
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4495
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Suturtek Incorporated
    Date Received
    August 11, 2003
    Decision Date
    September 23, 2003
    Product Code
    GAQ
    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
    GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

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    Other Clearances by Suturtek Incorporated

    K Number Device Name
    K082828 SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE
    K063603 SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17
    K030227 SUTURTEK FASTCLOSE SUTURING DEVICE