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

    AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER

    K Number: K061288 · Decision Nov 2, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    110
    Registration Numbers
    110
    Same Product Code
    172
    Applicant Total
    218
    Review Days
    177

    Basic Information

    Device Name
    AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER
    K Number
    K061288
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
    Date Received
    May 9, 2006
    Decision Date
    November 2, 2006
    Product Code
    FZP
    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
    FZP Clip, Implantable

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