BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DIGICAP

    K Number: K012199 · Decision Dec 19, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    159

    Basic Information

    Device Name
    DIGICAP
    K Number
    K012199
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    HUMANA USA, INC.
    Date Received
    July 13, 2001
    Decision Date
    December 19, 2001
    Product Code
    GAB
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GAB Needle, Suturing, Disposable

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