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

    Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe

    K Number: K211555 · Decision Oct 18, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    161
    Applicant Total
    12
    Review Days
    152

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe
    K Number
    K211555
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
    Date Received
    May 19, 2021
    Decision Date
    October 18, 2021
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MEG), ordered by most recent decision date.

    PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VaporShield

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SaviSafe Safety Device

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Shina Syringe; Shina Safety Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Medline Safety Insulin and TB Syringes

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

    K Number Device Name
    K234024 HWJECT Auto-disable syringe
    K230061 Insulin Syringe
    K230043 Insulin Pen Needle
    K223323 Blood Collection Needle (with/without Needle Holder)
    K222124 Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle
    K222141 Safety Blood Collection Needle (Without Needle Holder)
    K220900 Safety Blood Collection Needles with/without Needle Holder
    K220083 LDV((Low Dead Volume )Syringe
    K214075 Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)
    K202188 Safety Blood Collection Sets for Single Use
    Search all 12 clearances from Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. →