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

    MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL

    K Number: K010936 · Decision May 21, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    163
    Review Days
    54

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    Basic Information

    Device Name
    MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
    K Number
    K010936
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    W. L. Gore & Associates, Inc.
    Date Received
    March 28, 2001
    Decision Date
    May 21, 2001
    Product Code
    OXD
    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
    OXD Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OXD), ordered by most recent decision date.

    SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
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