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

    TRAY, URETHRAL CATHETERIZATION

    K Number: K760048 · Decision Mar 1, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    59
    Applicant Total
    4
    Review Days
    259

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    Basic Information

    Device Name
    TRAY, URETHRAL CATHETERIZATION
    K Number
    K760048
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    M-C Ind., Inc.
    Date Received
    June 15, 1976
    Decision Date
    March 1, 1977
    Product Code
    FCM
    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
    FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

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    Other Clearances by M-C Ind., Inc.

    K Number Device Name
    K760047 TRAY, BLADDER IRRIGATION
    K760051 TRAY, SUTURE REMOVAL
    K760052 KIT, PREP SHAVE