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

    FEMALE EXTERNAL URINARY APPLIANCE

    K Number: K823450 · Decision Dec 28, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    7
    Review Days
    41

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    Basic Information

    Device Name
    FEMALE EXTERNAL URINARY APPLIANCE
    K Number
    K823450
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Diamed Division Ill. Tool Works, Inc.
    Date Received
    November 17, 1982
    Decision Date
    December 28, 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 Diamed Division Ill. Tool Works, Inc.

    K Number Device Name
    K854953 DIAMED MODELS 600, 900, 960, 964
    K812281 TOUCHLESS HOME-CATH
    K802664 URINARY DRAINAGE UNT
    K802665 TOUCHLESS CLEAN-CATH
    K790728 TOUCHLESS TM FOLEY CATHETER KIT
    K760897 STERILE URETHRAL CATHETER KIT