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

    VitreJect Syringe

    K Number: K230372 · Decision Sep 8, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    6
    Applicant Total
    8
    Review Days
    207

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    Basic Information

    Device Name
    VitreJect Syringe
    K Number
    K230372
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ocuject, LLC
    Date Received
    February 13, 2023
    Decision Date
    September 8, 2023
    Product Code
    QLY
    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
    QLY Ophthalmic Syringe

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    Other Clearances by Ocuject, LLC

    K Number Device Name
    K242956 LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle
    K233343 SteriCap Safety Needle; VitreJect Safety Needle
    K230959 VitreJect® Needle; OcuSafe® Needle
    K212544 MiniLoad Syringe
    K212805 SteriCap Mini Needle and Standard Needles
    K202432 MiniLoad Syringe
    K170768 Mini Needle