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510(k) Data Aggregation

    K Number
    K131323
    Device Name
    ECLERIS SINUSCOPE
    Manufacturer
    Ecleris USA
    Date Cleared
    2014-06-09

    (397 days)

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

    Ecleris USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended to be a reusable instrument to provide the physician with a means for direct viewing of the nasal cavity by providing illumination and visualization of these regions during various diagnostic and therapeutic procedures.
    Device Description
    Ecleris Sinuscope
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    K Number
    K100595
    Device Name
    ECLERIS MICROSTAR COLPOSCOPE
    Manufacturer
    Ecleris USA
    Date Cleared
    2010-07-09

    (129 days)

    Product Code
    HEX
    Regulation Number
    884.1630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ecleris USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended to magnify the view of the vagina, cervix and external genitalia. It is used to diagnose abnormalities and select areas for biopsy.
    Device Description
    Not Found
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