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510(k) Data Aggregation

    K Number
    K152933
    Device Name
    Vesalius
    Date Cleared
    2016-03-23

    (170 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    TELEA ELECTRONIC ENGINEERING SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vesalius Essential device and its accessories are intended for resection, ablation and coagulation of soft tissues and haemostasis of blood vessels in surgical procedures in orthopedic, arthroscopic, neurosurgery, ENT, and spinal procedures.
    Device Description
    Not Found
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    K Number
    K131696
    Device Name
    VESALIUS
    Date Cleared
    2014-01-31

    (235 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    TELEA ELECTRONIC ENGINEERING SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vesalius, models Vesalius MCNplus and QUANTUM and accessories are intended for resection, ablation and coagulation of soft tissues and haemostasis of blood vessels in surgical procedures in orthopaedic, arthroscopic, neurosurgery, ENT, and spinal procedures.
    Device Description
    Not Found
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