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

    URETERAL STENT

    K Number: K920695 · Decision Sep 23, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    121
    Applicant Total
    13
    Review Days
    222

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    Basic Information

    Device Name
    URETERAL STENT
    K Number
    K920695
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Applied Urology, Inc.
    Date Received
    February 14, 1992
    Decision Date
    September 23, 1992
    Product Code
    FAD
    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
    FAD Stent, Ureteral

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    Other Clearances by Applied Urology, Inc.

    K Number Device Name
    K921838 ACUCISE URETERAL CUTTING CATHETER
    K925282 UROLOGICAL CATHETER AND ACCESSORIES
    K915219 URETHRAL ELECTRODE SHEATH
    K912093 DISPOSABLE ASPIRATION IRRIGATION SYSTEM
    K920030 SURESEAL ENDOSCOPIC VALVE
    K912656 ENDOSCOPIC ELECTRODE
    K912903 PERCUTANEOUS RETRACTOR KIT
    K905731 FLEXIBLE ENDOSCOPIC ELECTRODE
    K903994 URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION
    K901214 RIGID URETEROSCOPE
    Search all 13 clearances from Applied Urology, Inc. →