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510(k) Data Aggregation

    K Number
    K130117
    Device Name
    NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS
    Manufacturer
    NETWORK MEDICAL PRODUCTS, LTD.
    Date Cleared
    2013-10-29

    (286 days)

    Product Code
    HOZ
    Regulation Number
    886.4790
    Why did this record match?
    Applicant Name (Manufacturer) :

    NETWORK MEDICAL PRODUCTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Network Eye Spears and Points: Indicated for all microsurgical ophthalmic procedures for tissue manipulation and management of fluids in the operative field. Network Wicks and Drains: Indicated for all microsurgical ophthalmic procedures for management of fluids in the operative field. Network Shields: Indicated for placement on the cornea to moisten the cornea and shield the retina from intense operating light during ophthalmic surgery.
    Device Description
    Network Eve Spears, Points, Drains, Wicks and Shields are single devices designed for tissue manipulation, fluid management and shielding of light in ophthalmic surgery. Spears and points consist of a triangle of dry Polyvinyl Alcohol (formalized) Sponge (PVA) or Cellulose sponge, either attached to a polypropylene handle for handling or separate to be picked up by forceps. The triangular shape allows the surgeon to carry out pinpoint absorption of liguid. Drains and Wicks are PVA Sponges in various sizes and shapes for wicking of fluid away from the operative field. Shields are circular-shaped PVA Sponges that moisten the cornea and reduce the light intensity on the retina during surgery.
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