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510(k) Data Aggregation

    K Number
    K222452
    Device Name
    Disposable Automatically Retractable Safety Syringes (with detachable needle)
    Date Cleared
    2022-11-23

    (100 days)

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

    Shantou Wealy Medical Instrument CO.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Automatically Retractable Safety Syringes with detachable needle devices are indicated for use where a safe and reliable method for intramuscular and subcutaneous injection of medication in a patient is desired.
    Device Description
    The Disposable Automatically Retractable Safety Syringes (with Detachable Needle) devices are piston syringes, intended for medical purpose and consist of a calibrated hollow barrel and a movable plunger. The syringe works like a conventional hypodermic syringe except that the contaminated needle is retracted inside the syringe immediately after patient injection. The needle retracting mechanism is activated by a spring action mechanism after injection is completed. The exposed needle remains safely inside the syringe plunger for disposal. The Disposable Automatically Retractable Safety Syringes (with Detachable Needle) devices are sterile, single use, disposable and non-reusable.
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    K Number
    K210216
    Device Name
    Disposable Automatically Retractable Insulin Safety Syringe
    Date Cleared
    2022-03-04

    (401 days)

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

    Shantou Wealy Medical Instrument CO.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    Ask a specific question about this device

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