Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K082841
    Device Name
    SPINAL FORAMINOSCOPE
    Manufacturer
    BLAZEJEWSKI MEDI-TECH GMBH
    Date Cleared
    2009-09-09

    (348 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    BLAZEJEWSKI MEDI-TECH GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spinal Foraminoscope for lumbar access is indicated for endoscopic visualization in the lumbar region. The Spinal Foraminoscope for cervical access is indicated for visual inspection of the cervical spinal nerve roots and surrounding tissue.
    Device Description
    The Spinal Foraminoscope for lumbar access is an optical and fiberoptic-based rigid endoscope provided with a 2.8 or 3.7 mm working channel and two 1.5-mm irrigation channels and allowing insertion of 2.8-mm or 3.5-mm hand-held instruments. The Spinal Foraminoscope for cervical access is a fiberoptic-based rigid endoscope which shares the same design. It is provided with a 2.2-mm working and irrigation channel, has a 3.6- mm outer diameter and allows insertion of 2.0-mm hand-held instruments. The Spinal Foraminoscope may be attached to standard fiberoptic light sources and Storz, Olympus, Wolf and ACM cameras and video adapters.
    Ask a Question

    Page 1 of 1