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

    URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK

    K Number: K093653 · Decision Feb 23, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    3
    Review Days
    90

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    Basic Information

    Device Name
    URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK
    K Number
    K093653
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Uresil, LLC
    Date Received
    November 25, 2009
    Decision Date
    February 23, 2010
    Product Code
    KNT
    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
    KNT Tubes, Gastrointestinal (And Accessories)

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    Other Clearances by Uresil, LLC

    K Number Device Name
    K053245 GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER
    K041995 MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY