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510(k) Data Aggregation

    K Number
    K051800
    Device Name
    IN6 SAFETY SYRINGE, MODEL 3ML
    Date Cleared
    2005-10-21

    (108 days)

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

    IN6 INCUVESTOR INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The In6 Safety Syringe (3ml) is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe reuse and is a single use, disposable and retractable safety syringe which is intended for injection of medical fluids into the body.
    Device Description
    The In6 Safety Syringe (3ml) is sterile, single-use, disposable, Non-reusable, Retractable, Piston Syringe, provided with needle attached in place., 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). In6 Safety Syringe (3ml) works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. The needle retracting mechanism is activated by a spring action mechanism after injection is completed, while the exposed needle remains safely inside the empty syringe barrel for disposal. The In6 Safety Syringe (3ml) consist of the following major components. 1. Plunger, 2. Barrel, 3. Piston, 4. O- Ring, 5. Spring, 6. Needle Hub, 7. U.V. Glue, 8. Cannula, 9. Needle Protector.
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