BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Disposable Automatically Retractable Insulin Safety Syringe

    K Number: K210216 · Decision Mar 4, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    161
    Applicant Total
    6
    Review Days
    401

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    Basic Information

    Device Name
    Disposable Automatically Retractable Insulin Safety Syringe
    K Number
    K210216
    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
    January 27, 2021
    Decision Date
    March 4, 2022
    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)
    K203613 ENFit Reusable Enteral Syringe
    K203410 ENFit Disposable Enteral Syringe
    K141640 AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE
    K113587 AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE)