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

    GAUZE SPONGE, X-RAY DETECTABLE

    K Number: K882708 · Decision Aug 3, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211
    Same Product Code
    110
    Applicant Total
    10
    Review Days
    37

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    Basic Information

    Device Name
    GAUZE SPONGE, X-RAY DETECTABLE
    K Number
    K882708
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4450
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Bioseal
    Date Received
    June 27, 1988
    Decision Date
    August 3, 1988
    Product Code
    GDY
    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
    GDY Gauze/Sponge, Internal, X-Ray Detectable

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    Other Clearances by Bioseal

    K Number Device Name
    K893814 SURGICAL INSTRUMENT KIT, DISPOSABLE
    K882695 RUBBER BAND, STERILE
    K882696 DERMICEL, MONTGOMERY STRAP
    K882694 FIXATION DEVICE, TRACH TUBE
    K882710 INTESTINAL SPONGES
    K882709 TONSIL SPONGE, X-RAY DETECTABLE, W/STRING
    K882707 GAUZE PACKING, X-RAY DETECTABLE
    K882711 GAUZE SPONGE 12PLY
    K882712 STICK SPONGE