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

    FEMALE URINARY INCONTINENCE SYS

    K Number: K843128 · Decision Jan 2, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    33
    Review Days
    146

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    Basic Information

    Device Name
    FEMALE URINARY INCONTINENCE SYS
    K Number
    K843128
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Chesebrough-Pond'S U.S.A. Co.
    Date Received
    August 9, 1984
    Decision Date
    January 2, 1985
    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 Chesebrough-Pond'S U.S.A. Co.

    K Number Device Name
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    K862803 CHESEBROUGH POND'S HYDROCOLLOID DRESSING
    K851383 BLISTERFILM TRANSPARENT DRESSING
    K851382 CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING
    K851539 CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLO
    K843567 KANGAROO NASOGASTRIC FEEDING TUBE
    K844186 CONTINENT STOMA SYSTEM & ACCESSORIES
    K845010 CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH
    K844789 KANGAROO ACCESS II ENTERAL FEEDING CONTAINER
    K843140 ISOLATE ADHESIVE BANDAGE FOR DRY WOUND
    Search all 33 clearances from Chesebrough-Pond'S U.S.A. Co. →