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

    CURITY LEG BAG

    K Number: K831121 · Decision Apr 28, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    63
    Review Days
    23

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    Basic Information

    Device Name
    CURITY LEG BAG
    K Number
    K831121
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    The Kendal Co.
    Date Received
    April 5, 1983
    Decision Date
    April 28, 1983
    Product Code
    KNX
    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
    KNX Collector, Urine, (And Accessories) For Indwelling Catheter

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    Other Clearances by The Kendal Co.

    K Number Device Name
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    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. →