LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K033390
    Device Name
    COLIBRI DISPOSABLE VITRECTOMY CUTTER
    Manufacturer
    MICROWORLD MEDICAL INSTRUMENTS, INC.
    Date Cleared
    2003-11-04

    (12 days)

    Product Code
    HQE
    Regulation Number
    886.4150
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROWORLD MEDICAL INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The COLIBRI Disposable Vitrectomy Cutter is intended to be used for the removal of vitreous and vitreal membranes during ophthalmic surgery.
    Device Description
    The COLIBRI Disposable Vitrectomy Cutter is a quillotine-style pneumatic handbiece for use during ophthalmic surgery. TThe main components of the device are the handle, diaphragm, inner spring, stainless steel inner and outer cutters, and attached tubing and connectors. The device provides cutting and aspiration functions during removal of vitreous and vitreal membranes in anterior and posterior segment surgeries. It is designed to be used with 20 psi and 30 psi ophthalmic surgical systems.
    Ask a Question

    Page 1 of 1