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

    CURITY URETERAL STENT

    K Number: K854862 · Decision Feb 10, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    121
    Applicant Total
    63
    Review Days
    67

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    Basic Information

    Device Name
    CURITY URETERAL STENT
    K Number
    K854862
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    The Kendal Co.
    Date Received
    December 5, 1985
    Decision Date
    February 10, 1986
    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 The Kendal Co.

    K Number Device Name
    K000087 MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR
    K990500 KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C
    K991758 MONOJECT INSULIN SYRINGE
    K970969 KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET
    K951488 KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP
    K942664 KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM
    K942774 POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING
    K892434 KENDALL CURITY OXYGEN MASK
    K892438 KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES
    K892440 KENDALL CURITY EXTENSION TUBES
    Search all 63 clearances from The Kendal Co. →