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510(k) Data Aggregation

    K Number
    K192499
    Device Name
    Cyber Blade
    Manufacturer
    Date Cleared
    2020-07-31

    (324 days)

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

    Sidam s.r.l

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Cyber BLADE is intended for use under endoscopic visualization and removal of dissected benign prostatic hyperplasia (BPH) tissue during endoscopic surgical procedures in urology.
    Device Description
    Cyber Blade provides efficient and rapid morcellation under endoscopic visualization. The cutting action is driven by the motor in the handpiece. Cyber Blade comprises: a single use sterile blade fixed to a handpiece where controls are placed, a re-usable internal motor provided with integrated battery pack, an AC powered charger for the battery pack. Cyber blade is also supplied with aspiration tubing and canister for the collection of evacuated tissue.
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