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

    URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION

    K Number: K903994 · Decision Oct 19, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    13
    Review Days
    51

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    Basic Information

    Device Name
    URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION
    K Number
    K903994
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Applied Urology, Inc.
    Date Received
    August 29, 1990
    Decision Date
    October 19, 1990
    Product Code
    FGF
    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
    FGF Catheter, Ureteral Disposable (X-Ray)

    Other Clearances by Applied Urology, Inc.

    K Number Device Name
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    K915219 URETHRAL ELECTRODE SHEATH
    K912093 DISPOSABLE ASPIRATION IRRIGATION SYSTEM
    K920030 SURESEAL ENDOSCOPIC VALVE
    K912656 ENDOSCOPIC ELECTRODE
    K912903 PERCUTANEOUS RETRACTOR KIT
    K905731 FLEXIBLE ENDOSCOPIC ELECTRODE
    K901214 RIGID URETEROSCOPE
    Search all 13 clearances from Applied Urology, Inc. →