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510(k) Data Aggregation

    K Number
    K191330
    Device Name
    Arc Enterocuff
    Manufacturer
    Boddingtons Plastics Ltd
    Date Cleared
    2020-01-31

    (260 days)

    Product Code
    FDA
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Boddingtons Plastics Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be attached to the distal end or the enteroscopes to facilitate endoscopic therapy, to be used for the following: - . Keeping the suitable depth of the enteroscope's view field - . Helping the endoscope with being inserted into the gastrointestinal tract
    Device Description
    Not Found
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    K Number
    K191067
    Device Name
    Arc Endocuff Glide AEG110 & AEG120
    Manufacturer
    Boddingtons Plastics Ltd
    Date Cleared
    2019-05-30

    (38 days)

    Product Code
    FED
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Boddingtons Plastics Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following: - keeping the suitable depth of endoscope's view field - helping the endoscope with being inserted into the gastrointestinal tract
    Device Description
    Not Found
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    K Number
    K162205
    Device Name
    Arc EndoCuff and Arc EndoCuff Vision
    Manufacturer
    BODDINGTONS PLASTICS LTD
    Date Cleared
    2016-12-09

    (126 days)

    Product Code
    FED
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    BODDINGTONS PLASTICS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following: - Keeping the suitable depth of endoscope's view field - Helping the endoscope with being inserted into the gastrointestinal tract
    Device Description
    The Arc EndoCuff and Arc Endocuff Vision have short tube like shape with flexible hairs and is attached to the distal end of the endoscope to facilitate endoscopic therapy. The Arc EndoCuff and Arc Endocuff Vision are designed to fit specific endoscopes (as designated on the packaging), and is supplied sterile following radiation sterilization and is single use only. The Arc EndoCuff and Arc Endocuff Vision are cylindrical shaped all polymer products. They utilise the combined properties of two polymer materials to self-retain to the designated endoscope(s). The products feature a number of flexible "hairs" that fold within the structure of the product during intubation and forward movement when in use, and open out when drawn backward to control field of view. Both the Arc EndoCuff and Arc Endocuff Vision devices are manually pushed onto the tip of the endoscope. It is designed to grip the endoscope sufficiently so as to prevent dislodgment during the procedure but without causing damage to the endoscope. At the end of the procedure, the device is removed either manually or with a purpose designed disposable tool before the endoscope is reprocessed. The endoscope fitted with the Arc EndoCuff or Arc Endocuff Vision is inserted into the intestine either through the anus or a stoma and is used in the standard manner. The EndoCuff stabilizes the tip of the instrument in the bowel lumen enabling the shaft of the Arc endoscope to be more easily straightened on pulling back so avoiding excessive looping. This is because the cuff maintains the position of the tip without having to angle it acutely against the bowel wall to gain purchase. The device does not hinder forward motion or cause trauma. During extubation, the device enables tip withdrawal in a more controlled fashion and provides improved visualisation by opening up the intestinal lumen for careful examination. Mucosal folds are everted and flattened enabling a more complete view of the areas of the bowel wall that were hidden behind mucosal folds.
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    K Number
    K151801
    Device Name
    Arc Endocuff Vision
    Manufacturer
    BODDINGTONS PLASTICS LTD
    Date Cleared
    2015-08-13

    (42 days)

    Product Code
    FED
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    BODDINGTONS PLASTICS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following: ·Keeping the suitable depth of endoscope's view field •Helping the endoscope with being inserted into the gastrointestinal tract
    Device Description
    Not Found
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    K Number
    K122565
    Device Name
    ARC ENDOCUFF
    Manufacturer
    BODDINGTONS PLASTICS LTD
    Date Cleared
    2012-09-04

    (13 days)

    Product Code
    FED
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    BODDINGTONS PLASTICS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following: - Keeping the suitable depth of endoscope's view field - Helping the endoscope with being inserted into the gastrointestinal tract
    Device Description
    The Arc EndoCuff has a short tube like shape with flexible hairs and is attached to the distal end of the endoscope to facilitate endoscopic therapy. The Arc EndoCuff is designed to fit specific endoscopes (as designated on the packaging), and is supplied sterile following radiation sterilization and is single use only.
    Ask a Question

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