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510(k) Data Aggregation

    K Number
    K230948
    Device Name
    BFlex™ 2 Slim 3.8 Single-Use Bronchoscope
    Date Cleared
    2023-05-03

    (29 days)

    Product Code
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    Verathon Medical (Canada) ULC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BFlex™ 2 Slim 3.8 Single-Use Bronchoscope is intended to work with the video monitor, in conjunction with nonpowered endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
    Device Description
    The BFlex™ 2 Slim 3.8 Single-Use Bronchoscope is a component to the BFlex™ Single-Use Bronchoscope System. The BFlex™ Single-Use Bronchoscope system consists of a single-use flexible bronchoscope, a reusable monitor, and a reusable cable. The BFlex™ 2 Single-Use Bronchoscope System provides real time viewing and recording for a wide range of airway procedures.
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    K Number
    K211947
    Device Name
    GlideScope BFlex 2.8 Single-Use Bronchoscope
    Date Cleared
    2021-11-03

    (133 days)

    Product Code
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    Verathon Medical (Canada) ULC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GlideScope® BFlex™ Single-Use Bronchoscopes are intended to work with a video monitor, in conjunction with non-powered endoscopic accessories and other equipment for endoscopy within the airways and tracheobronchial tree.
    Device Description
    The GlideScope® BFlex™ 2.8 Single-Use Bronchoscope is one component of the GlideScope® BFlex™ Single-Use Bronchoscope System. The system consists of a single-use flexible bronchoscope, a reusable monitor, and a reusable cable. The GlideScope® BFlex™ Single-Use Bronchoscope System is intended to provide real time viewing and recording for a wide range of airway procedures. Similar to the predicate GlideScope® BFlex™ 3.8, 5.0, and 5.8 Single-Use Bronchoscopes, the GlideScope® BFlex™ 2.8 Single-Use Bronchoscope is distributed sterile and is for single use only. The GlideScope® BFlex™ bronchoscopes operate with a portable reusable GlideScope video monitor (GVM or Core monitors) for purposes of image display.
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    K Number
    K193488
    Device Name
    GlideScope BFlex 3.8 Single-Use Bronchoscope
    Date Cleared
    2020-01-16

    (30 days)

    Product Code
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    Verathon Medical (Canada) ULC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GlideScope® BFlex™ Single-Use Bronchoscopes are intended to work with the video monitor, in conjunction with nonpowered endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
    Device Description
    The GlideScope® BFlex™ 3.8 Single-Use Bronchoscope is one component of the GlideScope® BFlex™ Single-Use Bronchoscope System. The system consists of a single-use flexible bronchoscope, a reusable monitor, and a reusable cable. The GlideScope® BFlex™ Single-Use Bronchoscope System is intended to provide real time viewing and recording for a wide range of airway procedures. Similar to the predicate GlideScope® BFlex™ 5.0 and 5.8 Single-Use Bronchoscopes, the GlideScope® BFlex™ 3.8 Single-Use Bronchoscope is distributed sterile and is for single use only. The GlideScope® BFlex™ bronchoscopes operate with a portable reusable GlideScope video monitor (GVM or Core monitor) for purposes of image display.
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    K Number
    K191948
    Device Name
    GlideScope BFlex 5.8 Single-Use Bronchoscope
    Date Cleared
    2019-08-21

    (30 days)

    Product Code
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    Verathon Medical (Canada) ULC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GlideScope® BFlex™ Single-Use Bronchoscopes are intended to work with the video monitor, in conjunction with nonpowered endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
    Device Description
    The GlideScope® BFlex™ 5.8 Single-Use Bronchoscope is one component of the GlideScope® BFlex™ Single-Use Bronchoscope System. The system consists of a single-use flexible bronchoscope, a reusable monitor, and a reusable cable. The GlideScope® BFlex™ Single-Use Bronchoscope System is intended to provide real time viewing and recording for a wide range of airway procedures. Similar to the predicate GlideScope® BFlex™ 5.0 Single-Use Bronchoscope, the GlideScope® BFlex™ 5.8 Single-Use Bronchoscope is distributed sterile and is for single use only. The GlideScope® BFlex™ bronchoscopes operate with a portable reusable GlideScope video monitor (GVM or Core monitor) for purposes of image display.
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    K Number
    K183256
    Device Name
    GlideScope BFlex Single-Use Bronchoscope System
    Date Cleared
    2019-01-04

    (44 days)

    Product Code
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    Verathon Medical (Canada) ULC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GlideScope® BFlex™ Single-Use Bronchoscope System are intended to work with the video monitor, in conjunction with non-powered endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree in adult patients.
    Device Description
    The GlideScope® BFlex™ Single-Use Bronchoscope System consists of a single-use flexible bronchoscope (5.0), a reusable monitor, and a reusable cable. The system is intended to provide real time viewing and recording for a wide range of airway procedures. The GlideScope® BFlex™ Single-Use Bronchoscope System is distributed sterile and is for single use only. The BFlex bronchoscope operates with a portable reusable GlideScope video monitor (GVM) for purposes of image display.
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