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

    CLOSED WOUND SUCTION DEVICE

    K Number: K883472 · Decision Oct 18, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    95
    Applicant Total
    28
    Review Days
    63

    Basic Information

    Device Name
    CLOSED WOUND SUCTION DEVICE
    K Number
    K883472
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4680
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS)
    Date Received
    August 16, 1988
    Decision Date
    October 18, 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 WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS)

    K Number Device Name
    K896800 IRRIGATION TRAY
    K896799 PARACERVICAL/PUDENDAL TRAYS
    K896559 INFANT FEEDING TUBE
    K896794 SPECIMEN CONTAINER
    K896806 CATHETER PLUG/PROTECTOR
    K896798 TRACHEOSTOMY TRAY
    K896797 SUCTION CATHETER KIT
    K896215 MERCY HIP/KNEE PACK
    K896804 MANIFOLD
    K896563 TUBING CONNECTORS
    Search all 28 clearances from WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) →