LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K213173
    Device Name
    TrabEx Pro
    Manufacturer
    MicroSurgical Technologies Inc
    Date Cleared
    2022-06-08

    (253 days)

    Product Code
    MRH
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    MicroSurgical Technologies Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TrabEx Pro Handpiece is a manual ophthalmic surgical instrument with irrigation and aspiration functions.
    Device Description
    The MicroSurgical Technology TrabEx Pro is a single use, sterile, manual ophthalmic knife. The device can be connected to an ophthalmic Irrigation/Aspiration (I/A) system to provide irrigation and aspiration while the procedure is being performed. TrabEx PRO has an incision sealing sleeve.
    Ask a Question

    Page 1 of 1