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510(k) Data Aggregation

    K Number
    K172128
    Device Name
    EsoFLIP® ES-310 Balloon Catheter
    Manufacturer
    Crospon Ltd.
    Date Cleared
    2017-11-22

    (131 days)

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

    PIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EsoFLIP® ES-310 balloon catheter is indicated for use to dilate esophageal strictures due to esophageal surgery, primary gastro-esophageal reflux and radiation therapy. Note: The EsoFLIP® ES-310 balloon catheter is to be used only with the EndoFLIP® system.
    Device Description
    The EsoFLIP® ES-310 catheter is a balloon dilation catheter. It is used by surgeons or gastroenterologists to dilate esophageal strictures due to esophageal surgery, primary gastroesophageal reflux, and radiation therapy. This indication for use is identical to the predicate EsoFLIP® ES-series (ES-320) predicate, K142000. The EsoFLIP® catheter connects to the EndoFLIP® imaging system in the same fashion as the predicate EsoFLIP® catheter, to display an image of the cross-sectional-areas (CSAs) of the dilation balloon, and to allow the balloon to be inflated using the EndoFLIP® syringe driver. In all cases the catheters are to only be used with the EndoFLIP® system.
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    K Number
    K142000
    Device Name
    ESOFLIP ES
    Manufacturer
    CROSPON, LTD.
    Date Cleared
    2014-09-25

    (64 days)

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

    PIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EsoFLIP® ES balloon catheter is indicated for use to dilate esophageal strictures due to esophageal surgery, primary gastro-esophageal reflux and radiation therapy. Note: The EsoFLIP® ES catheter is to be used only with the EndoFLIP® system.
    Device Description
    The EndoFLIP® system is an endoscopically placed device that utilizes a catheter for various indications. Crospon submitted and received 510(k) clearances for the EndoFLIP® System with a number of different catheters with different indications for use. This submission is seeking to expand the indication for use for the proposed EsoFLIP® ES catheter to dilate esophageal strictures due to esophageal surgery, primary gastro-esophageal reflux and radiation therapy. In all cases the catheters are to only be used with the EndoFLIP® system.
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