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

    TRAY, CATHERIZATION, URETHRAL

    K Number: K810249 · Decision Apr 7, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    237
    Applicant Total
    7
    Review Days
    68

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    Basic Information

    Device Name
    TRAY, CATHERIZATION, URETHRAL
    K Number
    K810249
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Megaplast, Inc.
    Date Received
    January 29, 1981
    Decision Date
    April 7, 1981
    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 Megaplast, Inc.

    K Number Device Name
    K822158 OPEN HEART TRAY (CUSTOM DESIGNED)
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    K820136 URINARY DRAINAGE BAG
    K810250 TRAY, IRRIGATION
    K810251 SYRINGE, ENT