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510(k) Data Aggregation

    K Number
    K060772
    Device Name
    MANUEL SAFTEY SYRINGE PARTS 1 & 2
    Manufacturer
    Date Cleared
    2006-10-16

    (208 days)

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

    MEDSAFE ASA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Manual Safety Syringe is a single-use safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.
    Device Description
    The Manual Safety Syringe is a single-use safety hypodermic syringe, which is very similar to a traditional syringe, with the exception that it possesses an integral needle retracting mechanism. The device comes in two variations: - 3. Manual Safety Syringe (2-parts) 5ml - 4. Manual Safety Syringe (3-parts) 5ml The Manual Safety Syringe (2-parts) consists of a conventional syringe barrel equipped with a mechanism that shall prevent re-use of an already used syringe. When the plunger is pressed in its bottom position the injection is completed. When retracting the plunger the snare will drag the needle into the barrel, and thus prevent reuse of the syringe. The cone prevents the needle from going back into the barrel during the injection. The nozzle holds the needle, snare and cone and is attached to the barrel prior to injection. The needle cap protects the needle when handled. Also, when pulled back, the plunger is unable to be detached from the barrel. As an additional safety feature the operator is encouraged to break off the plunger when the plunger has been pulled back. The Manual Safety Syringe (3-parts) is identical to the 2-parts version with respect to the operation of the device. The design differs only with respect to the plunger and the lubrication. The 3-parts version is equipped with an extra sealing and the inside of the barrel is lubricated with silicon. The 2-parts version is not lubricated. The Manual Safety Syringe is only available in one size (5ml).
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