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510(k) Data Aggregation

    K Number
    K160710
    Device Name
    Oasis Lacrimal Intubation Set
    Manufacturer
    ANODYNE
    Date Cleared
    2016-05-13

    (59 days)

    Product Code
    OKS
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANODYNE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oasis Medical Lacrimal Intubation Set is intended for use for nasolacrimal intubation in patients of age and older. Indications for nasolacrimal intubation performed with the Oasis Medical Lacrimal Intubation device are: - · Canalicular pathologies (e.g., congenital or acquired stenosis, lacerations) - · During dacryocystorhinostomy - · Congenital lacrimal duct obstruction
    Device Description
    The Oasis Lacrimal Intubation Set with Retrieval Device (Model Summary: 6004) is a sterile (via gamma sterilization-VDmax method-25kGy), single-use, hand held, and ophthalmic surgical device. The device consists of a twelve inch medical grade silicone tube that is secured at each end to two 4 ½", 23 gauge stainless steel, olivetipped probes along with a 3″ plastic handled retriever with a stainless steel hook. The Oasis Lacrimal Intubation Set with Retrieval Device is used by a physician for nasolacrimal intubation.
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