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510(k) Data Aggregation

    K Number
    K122417
    Device Name
    SCOPEVALET DISPOSABLE BIOPSY VALVE
    Manufacturer
    THE RUHOF CORP.
    Date Cleared
    2013-05-17

    (282 days)

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

    THE RUHOF CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ScopeValet Disposable Biopsy Valves, Model Numbers 345BVO and 345BVP, are intended to provide access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.
    Device Description
    The Ruhof Corporation ScopeValet Disposable Biopsy Valves can be manufactured with a choice of two types - regular disposable biopsy valve and irrigating biopsy valve. Each of these types can be ordered for Olympus, Fujinon, and Pentax gastrointestinal endoscopes.
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