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510(k) Data Aggregation

    K Number
    K052229
    Device Name
    COLOPLAST OSTOMY ROD, MODEL 12814
    Manufacturer
    COLOPLAST CORP.
    Date Cleared
    2006-10-13

    (423 days)

    Product Code
    EZP
    Regulation Number
    876.4270
    Why did this record match?
    Product Code :

    EZP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Coloplast Ostomy Rod is used for loop ostomy surgery. The ostomy rod is a device that is placed through a loop of the colon brought out through the abdominal wall to temporarily keep it from slipping back through the surgical opening during the loop (colostomy or ileostomy) ostomy procedure.
    Device Description
    The Coloplast Ostomy Rod is a 90mm white HDPE rod with a fixed T at one end and a separate T piece that can be snaoped into the open end of the rod once it is in place. Holes in the ends of the T allow for suturing. The device is packaged in a laminated polvethylene and cas-permeable paper pouch. The product is sterilized by irradiation.
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    K Number
    K040110
    Device Name
    EASY LOOP, MODEL EZL-01
    Manufacturer
    TOOLS FOR SURGERY, LLC
    Date Cleared
    2004-03-24

    (64 days)

    Product Code
    EZP
    Regulation Number
    876.4270
    Why did this record match?
    Product Code :

    EZP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Easy Loop is indicated for use in abdominal surgical procedures generally referred the Lady Loop is mare specifically referred to as loop ileostomy and loop colostomy, where a loop of bowel is pulled through an abdominal incision and retained colosiony, which a loop of bonet to pair in paints the exteriorized loop of bowel from retracting back into the abdominal cavity, is used in conjunction with commercially available ostomy appliances which collect the evacuated feces.
    Device Description
    The Easy Loop is constructed of an eight inch long x 0.28" diameter PVC flexible tubing, to which is bonded at each end a 1.45" long generally arrowshaped slotted PVC coupling member whose shape allows easy passage through the mesentery for placement of the device while resisting unintended withdrawal , and whose shape and slots permit interlocking of the two ends of the device to form a closed loop around the exteriorized loop of bowel.
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