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

    FEMALE EXTERNAL URINARY COLLECTION POUCH

    K Number: K971499 · Decision Aug 28, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    6
    Applicant Total
    2
    Review Days
    125

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    Basic Information

    Device Name
    FEMALE EXTERNAL URINARY COLLECTION POUCH
    K Number
    K971499
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mediquest, Inc.
    Date Received
    April 25, 1997
    Decision Date
    August 28, 1997
    Product Code
    EXI
    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
    EXI Device, Paste-On For Incontinence, Sterile

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