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

    SUTURTEK FASTCLOSE SUTURING DEVICE

    K Number: K030227 · Decision Mar 17, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    29
    Applicant Total
    4
    Review Days
    54

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    Basic Information

    Device Name
    SUTURTEK FASTCLOSE SUTURING DEVICE
    K Number
    K030227
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4830
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Suturtek Incorporated
    Date Received
    January 22, 2003
    Decision Date
    March 17, 2003
    Product Code
    GAL
    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
    GAL Suture, Absorbable, Natural

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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
    K032468 SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE