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510(k) Data Aggregation

    K Number
    K102733
    Device Name
    VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR
    Manufacturer
    VISION-SCIENCES, INC.
    Date Cleared
    2011-05-18

    (238 days)

    Product Code
    EOB, GCJ, HRX
    Regulation Number
    874.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISION-SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The flexible ENT-5000 Video ENT Scope with EndoSheath® Technology is intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages; and for use in diagnostic arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The digital video processor is intended for use with the VSI flexible video scope.
    Device Description
    The VSI endoscopes are flexible endoscopes with connections to a video processor and display monitor. The EndoSheath® Techology for the ENT-5000 are optional, sterile, single-use protective sheath systems, with or without a working channel, that are intended to cover the entire insertion tube of the videoscope. The digital video processors are used with the flexible videoscopes for image visualization and capture.
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    K Number
    K100125
    Device Name
    VISION SCIENCES FLEXIBLE ENT SCOPE
    Manufacturer
    VISION-SCIENCES, INC.
    Date Cleared
    2010-02-25

    (37 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISION-SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vision Sciences' Flexible ENT Scope is intended for flexible endoscopic examination of the upper airway, vocal chords and/or nasal passages.
    Device Description
    The ENT-3000 Scope and BLS-1000 offers optimal portability for endoscopic viewing. LED based illumination provides bright white light for endoscopic viewing.
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    K Number
    K091768
    Device Name
    VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES
    Manufacturer
    VISION-SCIENCES, INC.
    Date Cleared
    2009-08-03

    (48 days)

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

    VISION-SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The bronchoscope and EndoSheath® Technology are designed to be used for upper airway management: including endoscopic treatment, diagnosis, and intubation of the airways. The digital video processor is intended for use with the VSI flexible video scope.
    Device Description
    The VSI flexible endoscopes are flexible endoscopes with connections to a video processor and display monitor. The EndoSheath® Systems are sterile, single-use protective sheath systems, with or without a working channel, that are intended to avver the entire insertion tube of the videoscope. The digital video processors are used with the flexible videoscopes for image visualization and capture.
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    K Number
    K072180
    Device Name
    VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM
    Manufacturer
    VISION-SCIENCES, INC.
    Date Cleared
    2007-12-18

    (134 days)

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

    VISION-SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The flexible video cystoscope with digital video processor and disposable sheath system is intended for use in endoscopic access and examination of the lower urinary tract, including the bladder and, using additional accessories, to perform various diagnostic and therapeutic procedures. The digital video processor is intended for use with the VSI flexible video scope.
    Device Description
    The VSI flexible endoscope is a flexible endoscope with connections to a video processor and display monitor. The EndoSheath® Systems are sterile, single-use protective sheath systems, with or without a working channel, that are intended to cover the entire insertion tube of the videoscope. The digital video processors are used with the flexible videoscope for image visualization and capture.
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    K Number
    K071127
    Device Name
    FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM
    Manufacturer
    VISION-SCIENCES, INC.
    Date Cleared
    2007-11-16

    (207 days)

    Product Code
    HIH
    Regulation Number
    884.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISION-SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CST-2000A and Slide-On® EndoSheath® System provides for endoscopic access and examination of the lower urinary tract including the bladder, and using additional accessories, to perform various diagnostic and therapeutic procedures. The CST-2000A and Slide-On® EndoSheath® System is used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and therapeutic/surgical procedures. Note: The CST-2000A and Slide-On Endosheath System is not indicated for electrosurgical procedures.
    Device Description
    The device system described in this 510(k) consists of a flexible, fiberoptic endoscope and sterile, single use protective sheath. This 510(k) adds a hysteroscopy indication to the currently marketed VSI Cystoscope with EndoSheath® System.
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    K Number
    K072073
    Device Name
    VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR
    Manufacturer
    VISION-SCIENCES, INC.
    Date Cleared
    2007-08-29

    (30 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISION-SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The flexible ENT videoscopes with digital video processor and disposable sheath systems are intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages and, using additional accessories, to perform various diagnostic and therapeutic procedures. The flexible ENT videoscope with EndoSheath® System is intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages. The digital video processor is intended for use with the VSI flexible video scope.
    Device Description
    The VSI flexible endoscopes are flexible endoscopes with connections to a video processor and display monitor. The EndoSheath® Systems are sterile, single-use protective sheath systems, with or without a working channel, that are intended to cover the entire insertion tube of the videoscope. The digital video processors are used with the flexible videoscopes for image visualization and capture.
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    K Number
    K072088
    Device Name
    FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS
    Manufacturer
    VISION-SCIENCES, INC.
    Date Cleared
    2007-08-29

    (30 days)

    Product Code
    EOX
    Regulation Number
    874.4710
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISION-SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The flexible trans-nasal video esophagoscope with digital video processor and disposable sheath system is intended for use in endoscopic access and examination of the larynx, esophagus and gastro-esophageal junction. The system can also be used to aid in intubation. The digital video processor is intended for use with the VSI flexible video scope.
    Device Description
    The VSI flexible endoscope is a flexible endoscope with connections to a video processor and display monitor. The EndoSheath® Systems are sterile, single-use protective sheath systems, with or without a working channel, that are intended to cover the entire insertion tube of the videoscope. The digital video processors are used with the flexible videoscope for image visualization and capture.
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    K Number
    K071903
    Device Name
    ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE
    Manufacturer
    VISION-SCIENCES, INC.
    Date Cleared
    2007-08-02

    (23 days)

    Product Code
    EOX, DEV, FDA
    Regulation Number
    874.4710
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISION-SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The flexible trans-nasal esophagoscope with sheath system is intended for use in endoscopic access and examination of the larynx, esophagus and gastro-esophageal junction. The device may also be used to assist intubation.
    Device Description
    The VSI EndoSheath® Systems are sterile, single-use protective sheath systems, with or without a working channel, that are intended to cover the entire insertion tube of the flexible endoscope.
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    K Number
    K053560
    Device Name
    MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE
    Manufacturer
    VISION-SCIENCES, INC.
    Date Cleared
    2006-03-16

    (85 days)

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

    VISION-SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For endoscopic access and examination of the lower urinary tract including the bladder and, using additional accessories, to perform various diagnostic and therapeutic procedures.
    Device Description
    The device system described in this 510(k) consists of a flexible, fiberoptic cystoscope and sterile, single use protective sheath.
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    K Number
    K050972
    Device Name
    VISION-SCIENCES ENT-3000 SCOPE
    Manufacturer
    VISION-SCIENCES, INC.
    Date Cleared
    2005-04-29

    (11 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISION-SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The scope is indicated for use during flexible endoscopic examination of the upper airway, vocal chords and/or nasal passages. The VSI Flexible ENT Scope is intended for flexible endoscopic examination of the upper airway, vocal chords and/or nasal passages.
    Device Description
    The device described in this 510(k) consists of modified flexible fiberoptic ENT scope. The scope has been modified to replace the integral light guide cable with a battery-powered LED light source (with accessory recharger).
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