BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    EZ-Injec LDV Sterile Safety Needle

    K Number: K210444 · Decision Feb 16, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    2
    Applicant Total
    6
    Review Days
    —

    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
    EZ-Injec LDV Sterile Safety Needle
    K Number
    K210444
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Poonglim Pharmatech, Inc.
    Date Received
    February 16, 2021
    Decision Date
    February 16, 2021
    Product Code
    QNS
    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
    QNS Low Dead Space Needle, Single Lumen, Hypodermic

    Similar 510(k) Clearances

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

    LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STERiJECT Low Dead Space, STERiJECT The Invisible Needle

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

    Other Clearances by Poonglim Pharmatech, Inc.

    K Number Device Name
    K241190 PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
    K221860 PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
    K210443 PLPT LDV (Low Dead Volume) Sterile Syringe
    K192222 EZ-Inject Single use Needle
    K172483 Kopac Sterile Needle