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510(k) Data Aggregation

    K Number
    K180026
    Device Name
    Bowel Management Device, Bowel Management Irrigation Set
    Manufacturer
    Applied Medical Technology, Inc.
    Date Cleared
    2018-06-01

    (149 days)

    Product Code
    KNT, EXD, PIF
    Regulation Number
    876.5980
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    Matched: '876.5895'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bowel Management Device is intended to instill fluids through a stoma into the colon to promote evacuation of the contents of the lower bowel through the anus and is intended to be an aid in the management of fecal incontinence. The catheter is placed and maintained in a percutaneously prepared opening, such as a cecostomy or appendicostomy. The Bowel Management Device is intended to be used in children and adults. The Bowel Management Irrigation Set is intended to allow connection between a compatible bowel management device and the delivery tubing of an irrigation/enema bag system.
    Device Description
    The Bowel Management Device is an indwelling low profile catheter used to promote evacuation of the lower bowel through antegrade colonic flushing. It consists of an internal retention balloon and a flexible external bolster with a balloon fill-valve, interlock irrigation port, and safety plug. The catheter is inserted through the stoma and into the colon and is secured by the internal retention balloon when inflated. The Bowel Management Irrigation Set has a connector on one end that connects to the interlock on the catheter and an adapter on the other end to connect to the irrigation/enema delivery system. Fluids can then be instilled directly into the colon through the catheter.
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    K Number
    K121833
    Device Name
    OSTOMY IRRIGATION SET
    Manufacturer
    COLOPLAST A/S
    Date Cleared
    2012-07-16

    (24 days)

    Product Code
    EXD
    Regulation Number
    876.5895
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Irrigation Set is indicated for people with a stoma who want to irrigate.
    Device Description
    The Irrigation Set is a Class II device, consisting of a single-use sleeve; a water bag (500-2000 ml) to hold water, a regulator where the paddle wheel that is integrated in the regulator gives visual assurance that water is entering the colon, a tube with a cone-shaped tip, a press plate and belt which are reusable devices. The Irrigation Set is provided with a nylon storage case.
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    K Number
    K982500
    Device Name
    CHAIT CECOSTOMY CATHETER
    Manufacturer
    COOK, INC.
    Date Cleared
    1999-01-27

    (191 days)

    Product Code
    KNT
    Regulation Number
    876.5980
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    Matched: '876.5895'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Chait Cecostomy Catheter is used to instill fluids through a cecostomy into the colon to promote evacuation of the contents of the lower bowel through the anal opening and is intended to be an aid in the management of fecal incontinence. The opening and is and maintained in a percutaneously prepared opening such as a cecostomy .
    Device Description
    The Chait Cecostomy Catheter is a "trap door", low profile catheter which facilitates antegrade colonic flushing. The device is supplied sterile and is intended for one time use. A tract must be established through the abdomen into the cecum prior to placement of the trap door catheter. Accessories used in conjunction with this device include, but are not limited to, a metal stiffener, a wire guide, a connecting tube, a syringe and saline solution. The device consists of a cecostomy catheter with a trap door attachment and an access adapter. The 10.2 French catheter is made of urethane and is manufactured with five (total) pigtail curves. The distal end of the catheter includes three sideports which are evenly spaced inside the fifth curve. The endhole is 0.038 inches in diameter. The total length of the catheter is 20cm. The trap door fitting is also made of urethane and lies flat against the abdomen wall. It incorporates a plastic plug which locks securely into place when the catheter is not being accessed. The access adapter is a metal cannula. The distal end of the cannula is curved and can be attached to the trap door fitting as needed to fluids through the Chait Cecostomy Catheter and into the cecum. The proximal end of the cannula is designed with a large tapered fitting that will fit most taper tip syringes.
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