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

    RIGID URETEROSCOPE

    K Number: K901214 · Decision Jun 1, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    112
    Applicant Total
    13
    Review Days
    79

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    Basic Information

    Device Name
    RIGID URETEROSCOPE
    K Number
    K901214
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Applied Urology, Inc.
    Date Received
    March 14, 1990
    Decision Date
    June 1, 1990
    Product Code
    FGB
    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
    FGB Ureteroscope And Accessories, Flexible/Rigid

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    Other Clearances by Applied Urology, Inc.

    K Number Device Name
    K921838 ACUCISE URETERAL CUTTING CATHETER
    K925282 UROLOGICAL CATHETER AND ACCESSORIES
    K920695 URETERAL STENT
    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
    Search all 13 clearances from Applied Urology, Inc. →