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

    EXTERNAL FEMALE URINARY INCONTINENCE

    K Number: K821172 · Decision May 10, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    29
    Review Days
    14

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    Basic Information

    Device Name
    EXTERNAL FEMALE URINARY INCONTINENCE
    K Number
    K821172
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    The Healthcare Group Laboratories, Inc.
    Date Received
    April 26, 1982
    Decision Date
    May 10, 1982
    Product Code
    KNX
    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
    KNX Collector, Urine, (And Accessories) For Indwelling Catheter

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    Other Clearances by The Healthcare Group Laboratories, Inc.

    K Number Device Name
    K850035 EMPTY SOLUTION TRANSFER CONTAINER
    K842170 EMPTY SOLUTION TRANSFER CONTAINER
    K842091 DISPOS. ACU-CUT SOFT TISSUE BIOPSY
    K840742 RIGHT ATRIAL CATHETER
    K830299 SOLUTION TRANSFER CONTAINER
    K822307 ADHESIVE SPRAY #4050-4060
    K822059 SHOW'RBAG
    K821480 RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT
    K821230 SOFTIC 49
    K821162 ADHESIVE REMOVER
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