LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K022186
    Device Name
    SCLERAL PLUGS, 19 AND 20 GAUGE
    Manufacturer
    MICROVISION, INC.
    Date Cleared
    2003-02-26

    (236 days)

    Product Code
    LXP
    Regulation Number
    886.4155
    Why did this record match?
    Product Code :

    LXP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The scleral plugs are intended to maintain patency of a previously made incision in the sclera of the eye, during ophthalmic surgical procedures.
    Device Description
    Scleral plugs, 19 and 20 gauge, for use in ophthalmic surgical procedures. Both 19 and 20 gauge plugs are stainless steel. The 19 gauge plugs are gold plated.
    Ask a Question
    K Number
    K990872
    Device Name
    SCLERAL PLUGS, 19 AND 20 GAUGE
    Manufacturer
    OPHTHALMIC CONSULTANTS, INC.
    Date Cleared
    1999-07-13

    (119 days)

    Product Code
    LXP
    Regulation Number
    886.4155
    Why did this record match?
    Product Code :

    LXP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The scleral plugs are provided as part of single- and multiple-use surgical component kits/packs, or as kit replacements, in order to maintain patency of a previously made incision in the sclera of the eye, during ophthalmic surgical procedures, performed by a certified clinician in a clinical setting.
    Device Description
    Scleral plugs, 19 and 20 ga., for use in ophthalmic surgical procedures. Both as stainless steel, with the 19 ga. plugs gold plated, and the 20 ga. plugs silver plated.
    Ask a Question

    Page 1 of 1