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510(k) Data Aggregation

    K Number
    K152597
    Device Name
    ProteXsure Safety Capsule System
    Manufacturer
    StarCap Medical LLC ( DBA Prism Medical & Design)
    Date Cleared
    2016-06-08

    (271 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    **StarCap Medical LLC ( DBA Prism Medical **& Design)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ProteXsure Safety Capsule System is intended as a single use needle protection device which covers the end of needles after use to minimize the risk of needle sticks. The device is designed for use with 25 Gauge to 31 Gauge needles. This device should only be used when a biohazard Sharps Container is not readily available.
    Device Description
    The ProteXsure Safety Capsule System is intended as a single use needle protection device which covers the end of needles after use to minimize the risk of needle sticks. The device is designed for use with 25 Gauge to 31 Gauge needles.
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