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510(k) Data Aggregation

    K Number
    K171619
    Device Name
    14Fr Colon Decompression Set, Macon Colon Decompression Set
    Manufacturer
    Cook Ireland Ltd
    Date Cleared
    2017-08-01

    (60 days)

    Product Code
    FEG
    Regulation Number
    876.5980
    Why did this record match?
    Product Code :

    FEG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is used for treatment of acute non-toxic megacolon, (Ogilvie's syndrome) and colonic strictures.
    Device Description
    The CDSG device consists of a colon decompression tube, guiding catheter and wire guide. The colon decompression tube is 14Fr in diameter with a length of 175cm. The device design includes side ports which allow for colon decompression. The device has connections to allow attachment to drainage collection bag or for the device to be flushed. The colon decompression tube, guiding catheter and wire guide can be observed fluoroscopically. The device is supplied sterile, intended for single use only. Use of this device is restricted to a trained healthcare professional. The CDSM device consists of a colon decompression tube and wire guide. The colon decompression tube is supplied in a range of diameter options, 7Fr. 8.5Fr and 10Fr. The colon decompression tube has a length of 350cm. The device design includes side ports which allow for colon decompression. The device has connections to allow attachment to drainage collection bag or for the device to be flushed. The colon decompression tube and wireguide can be observed fluoroscopically. The colon decompression tube has a design feature (pigtail) at the distal end of the device which helps reduce migration. The device is supplied sterile, intended for single use only. Use of this device is restricted to a trained healthcare professional. The same wire guide is supplied with both the CDSG and CDSM devices; the wire guide has a flexible distal ball tip.
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    K Number
    K132314
    Device Name
    MEDLINE ANTI-REFLUX VALVE
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2013-09-18

    (55 days)

    Product Code
    FEG
    Regulation Number
    876.5980
    Why did this record match?
    Product Code :

    FEG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medline Anti-Reflux Valve allows the vent lumen of the gastric sump tube to neutralize the vacuum pressure in the stomach when the contents are fully evacuated, but prevents stomach contents from exiting the vent lumen. This reduces the risk that healthcare workers will be exposed to potentially infectious gastric fluids and also prevents unnecessary patient bedding and gown changes.
    Device Description
    Not Found
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    K Number
    K053410
    Device Name
    GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR
    Manufacturer
    KENDALL
    Date Cleared
    2006-01-06

    (30 days)

    Product Code
    FEG
    Regulation Number
    876.5980
    Why did this record match?
    Product Code :

    FEG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication.
    Device Description
    The GiEntriport with Universal Single Lumen Adaptor is a multiport Device Description. The GiEnthport with Offirstal Surges or to a single lumen feeding tube.
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    K Number
    K040388
    Device Name
    NEXT GENERATION SALEM SUMP
    Manufacturer
    KENDALL
    Date Cleared
    2004-05-17

    (90 days)

    Product Code
    FEG
    Regulation Number
    876.5980
    Why did this record match?
    Product Code :

    FEG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Next Generation Salem Sump is intended for gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication, during the time period that gastric decompression is required.
    Device Description
    The Next Generation Salem Sump is a dual lumen Naso Gastric tube with a multiport connector/valve to facilitate switching among the various function of the device.
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    K Number
    K971354
    Device Name
    KNOTT NG TUBE
    Manufacturer
    MICHAEL M. KNOTT, M.D.
    Date Cleared
    1997-11-19

    (222 days)

    Product Code
    FEG
    Regulation Number
    876.5980
    Why did this record match?
    Product Code :

    FEG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To permit withdrawal, introduction of fluids into the stomach or removal of stomach gas via a tube inserted through the nostril.
    Device Description
    The Knott NG tube is designed to permit withdrawal or introduction of fluids through a tube which is inserted through the nostril and into the stomach.
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    K Number
    K960176
    Device Name
    DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    1996-07-24

    (190 days)

    Product Code
    FEG
    Regulation Number
    876.5980
    Why did this record match?
    Product Code :

    FEG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Davol Nasogastric Sump Tube with PreVent Anti-Reflux Filter is intended for gastric decompression, gastric lavage, and administration of nutritional supplements and medication.
    Device Description
    The Davol Nasogastric Sump Tube with PreVent Anti-Reflux Filter is a dual lumen device used for gastric decompression (removal of gastric secretions and gases), gastric lavage, and administration of nutritional supplements and medication. Nasogastric sump tubes are generally used with a suction source to facilitate gastric drainage. The primary suction lumen of the tube is used for drainage, the second lumen, the vent lumen, provides an air inlet as a mechanism to break suction minimizing the potential for tube blockage secondary to mucosal tissue invagination into the side holes of the primary suction lumen. With the dual lumen nasogastric sump tube, if the primary lumen becomes obstric contents can back up into the vent lumen causing spillage onto the patient and possible clinical staff exposure to the gastric contents. The PreVent Anti-Reflux Filter provided with the Davol Nasogastric Sump Tube prevents reflux from exiting the vent lumen and spilling from the vent tube. The anti-reflux filter was incorporated for convenience, so that the clinical staff would not have to contend with and be exposed to spilled gastric contents and subsequent patient gown and linen changes. Although spillage from the vent tube is prevented, the user is still able to visualize reflux in the vent tube and therefore, the ability to diagnose a blocked primary lumen is maintained.
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