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510(k) Data Aggregation

    K Number
    K221981
    Device Name
    SafeR Syringe and SafeR Sting
    Manufacturer
    Roncadelle Operations srl
    Date Cleared
    2022-12-29

    (177 days)

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

    Roncadelle Operations srl

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SafeR® is an automatically Retractable Safety Syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids and for the injection of fluids immediately after filling. It is intended to be used for the administration of medications (intramuscular (IM), intradermal (ID) and subcutaneous (SC)). SafeR® system is provided in 2 separate parts: SafeR Syringe and the needle group SafeR Sting, Before use, the end user needs to assemble syringe and needle group. The syringe, once assembled with his needle, incorporates a passive safety mechanism which retracts and contains the contaminated needle after use, aiding in prevention of possible infection due to needlestick injuries and syringe re-use. Needle retraction is activated by the syringe user with one hand. SafeR Sting blunt fill needle is designed only for drug preparation and it is not in contact with human body. SafeR Syringe with SafeR Sting maintain standard injection techniques.
    Device Description
    SafeR® (SafeR Syringe and SafeR Sting) is an automatically retractable safety syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids or for the injection of fluids immediately after filling. SafeR® system is composed by a body syringe (SafeR Syringe) and a needle group (SafeR Sting). SafeR Syringe and SafeR Sting are 2 (two) products, packaged and sold separately, but designed to be coupled for use. Before use, the end user needs to assemble the body syringe and needle group through a clockwise rotation. Body syringe and needle group are connected by means of a threaded connection and conical mating surfaces between Screw Connector and Barrel. Geometry of the threaded connection was designed to ensure appropriate coupling only between SafeR Sting screw connector and SafeR Syringe barrel. Once assembled with its needle (SafeR Sting), incorporates a passive safety mechanism which retracts and contains the contaminated needle into a hollow stem of the plunger after use, aiding in the prevention of possible infections due to needle stick injuries and syringe reuse. Needle retraction is activated by the syringe user with one hand. Its intended condition is sterile, single use, for hospital or home use.
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