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510(k) Data Aggregation

    K Number
    K201816
    Device Name
    ARTHROTAP
    Manufacturer
    Accuro Technologies Inc.
    Date Cleared
    2020-10-16

    (107 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Accuro Technologies Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ARTHROTAP is intended for use by healthcare professionals for general purpose fluid aspiration.
    Device Description
    The ARTHROTAP is a fluid switching medical device consisting of a clear plastic barrel body, a sliding rod, two 6% female Luer lock connections, and one 6% male Luer lock connection. The internal surface of the ARTHROTAP device barrel body is lubricated with polydimethylsiloxane (silicone). The ARTHROTAP is single-use only, non-pyrogenic, and sterilized by electron beam irradiation.
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