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510(k) Data Aggregation

    K Number
    K111734
    Device Name
    MYSAFETY SYRINGE
    Date Cleared
    2011-09-06

    (77 days)

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

    MEDICALCHAIN INTL. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MySafety Syringe is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe re-use and is a single use, disposable and retractable safety syringe which is intended for injection of medical fluids into the body.
    Device Description
    The submitted device MySafety Syringe is a 1cc / ml size, sterile, single-use, disposable, non-reusable, needle-retractable, piston syringe, provided with an attached needle , which is intended for the injection of medication into a patient, while minimizing the potential for accidental injury as a result of needle-stick ( sharps injury) and preventing syringe reuse. The submitted device MySafety® Syringe works like a conventional hypodermic syringe except for its ability to retract the used needle inside the syringe barrel at the end of injection. The needle retraction mechanism is activated as the following. "After injection is completed, remove the syringe from patient's body, add pressure to the plunger by pushing the plunger further ahead with one hand till you hear a clear audible "click" sound and you see the needle fully retracted into the syringe barrel."
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