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

    ASSIST(TM) ASEPTIC SYRINGE IRRIGATION SYSTEM

    K Number: K881981 · Decision Aug 2, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    237
    Applicant Total
    10
    Review Days
    82

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    Basic Information

    Device Name
    ASSIST(TM) ASEPTIC SYRINGE IRRIGATION SYSTEM
    K Number
    K881981
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Ryder Intl. Corp.
    Date Received
    May 12, 1988
    Decision Date
    August 2, 1988
    Product Code
    KOD
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KOD Catheter, Urological

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