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

    OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE

    K Number: K970716 · Decision May 16, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    127
    Applicant Total
    7
    Review Days
    78

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    Basic Information

    Device Name
    OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE
    K Number
    K970716
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Opticon Medical, Inc.
    Date Received
    February 27, 1997
    Decision Date
    May 16, 1997
    Product Code
    EZL
    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
    EZL Catheter, Retention Type, Balloon

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    K930194 HEMOSTASIS VALVE AND TUBING SET
    K904999 WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE
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