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

    3M PRECISE BRAND INTERNAL SURGICAL STAPLES

    K Number: K921051 · Decision Jul 16, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    282
    Applicant Total
    49
    Review Days
    133

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    Basic Information

    Device Name
    3M PRECISE BRAND INTERNAL SURGICAL STAPLES
    K Number
    K921051
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4750
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3M Health Care, Ltd.
    Date Received
    March 5, 1992
    Decision Date
    July 16, 1992
    Product Code
    GDW
    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
    GDW Staple, Implantable

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