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

    WOUND-EVAC RS

    K Number: K881012 · Decision Mar 17, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    213
    Registration Numbers
    213
    Same Product Code
    95
    Applicant Total
    2
    Review Days
    7

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    Basic Information

    Device Name
    WOUND-EVAC RS
    K Number
    K881012
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4680
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Heritage Medical Products
    Date Received
    March 10, 1988
    Decision Date
    March 17, 1988
    Product Code
    GCY
    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
    GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered

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    Other Clearances by Heritage Medical Products

    K Number Device Name
    K813341 WOUND-EVAC