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510(k) Data Aggregation

    K Number
    K221264
    Device Name
    FROG Forceps Valve (VAL1-F1-100)
    Date Cleared
    2022-06-01

    (30 days)

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

    FUJIFILM medwork GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The forceps valve is intended to facilitate passage of an endotherapy device, to prevent leak or back flow of air and/or fluids, and to enable the suction function of a FUJIFILM or Olympus gastrointestinal endoscope.
    Device Description
    The FROG forceps valve forms a tight seal with the biopsy port to prevent leakage of biomaterial, provide easy passage of endotherapy devices, and support the suction function.
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    K Number
    K210625
    Device Name
    JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve
    Date Cleared
    2021-09-10

    (192 days)

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

    FUJIFILM medwork GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The JAZZ Disposable Valve Kit is comprised of the JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve. The JAZZ Suction Valve is intended to control the suction (aspiration of air and fluids) of a FUIFILM gastrointestinal endoscope during endoscopy procedures. The JAZZ Air/Water Valve is intended to control air of a FUJIFILM gastrointestinal endoscope for insufflations and water delivery (for distal lens cleaning) during endoscopy procedures. The JAZZ Forceps Valve is intended to facilitate passage of an endotherapy device, to prevent a leak or backflow of air and/or fluids, and to enable the suction function of a FUJIFILM gastrointestinal endoscope.
    Device Description
    The JAZZ Disposable Valve Kit is comprised of the JAZZ Suction Valve, Air/Water Valve, and Forceps Valve. These devices are intended for single-use and are supplied sterile, eliminating the need for manual cleaning and reprocessing. These valves are designed to the corresponding port of a FUJIFILM G7 gastrointestinal endoscope. The air/water valve can be activated to control air and water flow, while the suction valve can be activated to aspirate excess fluids or other debris. The forceps valve forms a tight seal with the biopsy port to prevent leakage of biomaterial, provide easy passage of endotherapy devices, and support thesuction function.
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