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

    DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED

    K Number: K913302 · Decision Jul 23, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211
    Same Product Code
    110
    Applicant Total
    6
    Review Days
    364

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    Basic Information

    Device Name
    DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED
    K Number
    K913302
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4450
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Carwild Corp.
    Date Received
    July 25, 1991
    Decision Date
    July 23, 1992
    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 Carwild Corp.

    K Number Device Name
    K913303 LAP SPONGES, MODIFIED
    K833688 SUTURE REMOVAL KITS STERILE
    K791872 LAP SPONGES
    K791871 NEUROLOGICAL SPONGES (PATTIES)
    K791870 DISPOSABLE SPECIALITY SPONGES