BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SURGICAL TUBE HOLDER

    K Number: K831489 · Decision Dec 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    6
    Review Days
    216

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    Basic Information

    Device Name
    SURGICAL TUBE HOLDER
    K Number
    K831489
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    The Urology Group
    Date Received
    May 10, 1983
    Decision Date
    December 12, 1983
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by The Urology Group

    K Number Device Name
    K831703 COVERUPS
    K810739 SUCTION WOUND DRAINAGE DEVICE
    K810788 SURGICAL TUBE HOLDER
    K810787 UROLOGIC TUBE HOLDER
    K801629 COVER-ALL MALE INCONTINENCE DEVICE