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510(k) Data Aggregation

    K Number
    K213077
    Device Name
    Automatically Retractable Safety Syringe
    Manufacturer
    Zhejiang Lingyang Medical Apparatus Co., Ltd.
    Date Cleared
    2022-04-27

    (216 days)

    Product Code
    MEG,FMF,FMI
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Automatically Retractable Safety Syringe is used for aspiration of fluids from vials and a variety of fluid injections into the human body through subcutaneous and muscle.

    It has a detachable needle with a dedicated fitting. The Automatically Retractable Safety Syringe contains an inner mechanism used to allow the needle to be retracted inside the plunger of the syringe after the operator's thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.

    Device Description

    Automatically Retractable Safety Syringe

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the "Automatically Retractable Safety Syringe". It describes the indications for use and states that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt.

    Therefore, I cannot provide the requested information based on the text provided. This document is a regulatory approval, not a technical study report.

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