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510(k) Data Aggregation

    K Number
    K093653
    Device Name
    URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK
    Manufacturer
    URESIL, LLC
    Date Cleared
    2010-02-23

    (90 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    URESIL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Uresil Gastrostomy Catheter Kit is indicated for gastroenteric feeding or drainage.
    Device Description
    Not Found
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    K Number
    K053245
    Device Name
    GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER
    Manufacturer
    URESIL, LLC
    Date Cleared
    2005-12-20

    (29 days)

    Product Code
    FGE, GBO, GBX, LJE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    URESIL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For percutaneous drainage of abscesses, nephrostomy and other fluids.
    Device Description
    Not Found
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    K Number
    K041995
    Device Name
    MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY
    Manufacturer
    URESIL, LLC
    Date Cleared
    2004-08-19

    (27 days)

    Product Code
    GBO
    Regulation Number
    878.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    URESIL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Drainage Catheters are to be used for percutaneous drainage of abscesses, nephrostomies, and other fluids.
    Device Description
    Not Found
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