Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K222452
    Device Name
    Disposable Automatically Retractable Safety Syringes (with detachable needle)
    Manufacturer
    Shantou Wealy Medical Instrument CO.,Ltd.
    Date Cleared
    2022-11-23

    (100 days)

    Product Code
    MEG, FMF, FMI
    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 Authorized
    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.
    Ask a Question

    Page 1 of 1