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

    VISISTAT STAPLER

    K Number: K943719 · Decision Aug 24, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    18
    Applicant Total
    6
    Review Days
    23

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    Basic Information

    Device Name
    VISISTAT STAPLER
    K Number
    K943719
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4760
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pilling Weck, Inc.
    Date Received
    August 1, 1994
    Decision Date
    August 24, 1994
    Product Code
    GDT
    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
    GDT Staple, Removable (Skin)

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    Other Clearances by Pilling Weck, Inc.

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