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

    FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735

    K Number: K012929 · Decision Nov 19, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    91
    Applicant Total
    14
    Review Days
    80

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    Basic Information

    Device Name
    FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735
    K Number
    K012929
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Circon Video
    Date Received
    August 31, 2001
    Decision Date
    November 19, 2001
    Product Code
    FAJ
    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
    FAJ Cystoscope And Accessories, Flexible/Rigid

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    Other Clearances by Circon Video

    K Number Device Name
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    K011876 DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2
    K011849 MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS
    K012951 APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE
    K012925 DUR-8, MODELS DUR-8
    K012265 METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088
    K012153 LOWSLEY SUPRAPUBIC TRACTOR
    K011848 CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE
    K970595 CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP
    K914883 CIRCON ACMI GEN SURG INSTRU FOR MINI INVASIVE SURG
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