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510(k) Data Aggregation
K Number
K230948Device Name
BFlex 2 Slim 3.8 Single-Use Bronchoscope
Manufacturer
Date Cleared
2023-05-03
(29 days)
Product Code
Regulation Number
874.4680Why 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
K211947Device Name
GlideScope BFlex 2.8 Single-Use Bronchoscope
Manufacturer
Date Cleared
2021-11-03
(133 days)
Product Code
Regulation Number
874.4680Why 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
K193488Device Name
GlideScope BFlex 3.8 Single-Use Bronchoscope
Manufacturer
Date Cleared
2020-01-16
(30 days)
Product Code
Regulation Number
874.4680Why 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
K191948Device Name
GlideScope BFlex 5.8 Single-Use Bronchoscope
Manufacturer
Date Cleared
2019-08-21
(30 days)
Product Code
Regulation Number
874.4680Why 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
K183256Device Name
GlideScope BFlex Single-Use Bronchoscope System
Manufacturer
Date Cleared
2019-01-04
(44 days)
Regulation Number
874.4680Why 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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