BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Tamper Evident Cap For use with ENFit Syringes

    K Number: K170672 · Decision Oct 6, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    32
    Applicant Total
    7
    Review Days
    214

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    Basic Information

    Device Name
    Tamper Evident Cap For use with ENFit Syringes
    K Number
    K170672
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    International Medical Industries, Inc.
    Date Received
    March 6, 2017
    Decision Date
    October 6, 2017
    Product Code
    PNR
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PNR Enteral Syringes With Enteral Specific Connectors

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    Other Clearances by International Medical Industries, Inc.

    K Number Device Name
    K231095 Tamper Evident Cap
    K201031 NRFit® Caps, Male and Female Neuraxial Tip Caps
    K193192 Tamper Evident Cap
    K190305 Additive Cap
    K182545 Tamper Evident Cap with Male Luer Lock
    K173577 Guarded Luer Connector