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510(k) Data Aggregation

    K Number
    K965180
    Device Name
    STRAIGHTFIRE REUSABLE OPTICAL FIBERS (400,600,800,1000)
    Manufacturer
    MYRIADLASE, INC.
    Date Cleared
    1997-06-05

    (163 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    MYRIADLASE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Ablation and hemostasis in the treatment of gynecological and urological conditions, as well as multiple applications in gastroenterology and general surgery.
    Device Description
    The StrateFire™ Reusable Optical Fiber is a fiberoptic laser energy delivery system intended for use with any surgical laser equipment fitted with SMA-905 compatible connectors and designed to operate at wavelengths between 532 and 1400 nm. The StrateFire™ Reusable Optical Fiber consists of a 400, 600, 800 or 1,000 micron diameter fused silica optical fiber with a proximal SMA-905 connector for attaching to a medical laser. Fibers are supplied sterile in heat-sealed Tyvek and may be reused after cleaning and sterilization as directed in the labeling.
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