BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE

    K Number: K141640 · Decision Nov 19, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    161
    Applicant Total
    6
    Review Days
    153

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    Basic Information

    Device Name
    AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE
    K Number
    K141640
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shantou Wealy Medical Instrument Co.,Ltd
    Date Received
    June 19, 2014
    Decision Date
    November 19, 2014
    Product Code
    MEG
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MEG Syringe, Antistick

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    Other Clearances by Shantou Wealy Medical Instrument Co.,Ltd

    K Number Device Name
    K222452 Disposable Automatically Retractable Safety Syringes (with detachable needle)
    K210216 Disposable Automatically Retractable Insulin Safety Syringe
    K203613 ENFit Reusable Enteral Syringe
    K203410 ENFit Disposable Enteral Syringe
    K113587 AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE)