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510(k) Data Aggregation

    K Number
    K181819
    Device Name
    SMARTRELEASE Endoscopic Soft Tissue Release System
    Manufacturer
    MicroAire Surgical Instruments LLC
    Date Cleared
    2018-11-06

    (120 days)

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

    MicroAire Surgical Instruments LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroAire SMARTRELEASE® Endoscopic Soft Tissue Release System is indicated for use in minimally invasive ligament or fascia release: - Carpal tunnel release in the wrist - Cubital tunnel release in the elbow
    Device Description
    MicroAire's SMARTRELEASE® Endoscopic Soft Tissue Release System is comprised of four (4) components: The SMARTRELEASE® Endoscope, the SMARTRELEASE® Handpiece, the SMARTRELEASE® Standard and Low Profile Blade Assemblies and the SMARTRELEASE® Sterilization Tray. In addition, the system includes a set of FDA Class 1 Manual Surgical Instruments. The SMARTRELEASE® Handpiece, the SMARTRELEASE® Endoscope, and the Manual Surgical Instruments are re-usable after cleaning and subsequent sterilization in the SMARTRELEASE® Sterilization Tray. The SMARTRELEASE® Blade Assemblies are gamma sterilized, single-use devices.
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