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

    STERILE URETHRAL CATHETER KIT

    K Number: K760897 · Decision Aug 31, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    237
    Applicant Total
    7
    Review Days
    674

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    Basic Information

    Device Name
    STERILE URETHRAL CATHETER KIT
    K Number
    K760897
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Diamed Division Ill. Tool Works, Inc.
    Date Received
    October 26, 1976
    Decision Date
    August 31, 1978
    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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    Other Clearances by Diamed Division Ill. Tool Works, Inc.

    K Number Device Name
    K854953 DIAMED MODELS 600, 900, 960, 964
    K823450 FEMALE EXTERNAL URINARY APPLIANCE
    K812281 TOUCHLESS HOME-CATH
    K802664 URINARY DRAINAGE UNT
    K802665 TOUCHLESS CLEAN-CATH
    K790728 TOUCHLESS TM FOLEY CATHETER KIT