BEUDAMED
    Product Code: QLY FDA class 2 21 CFR 880.5860

    Ophthalmic Syringe

    General Hospital

    The Ophthalmic Syringe is a piston syringe specifically designed for intraocular injections, consisting of a calibrated hollow barrel, a movable plunger, and optionally a needle. It is intended for use by healthcare professionals to perform precise injections into the eye. This device is classified as FDA Class 2, requiring 510(k) premarket clearance, under regulation 880.5860. It carries product code QLY and falls within the General Hospital medical specialty. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    7
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    6
    Years Active
    5

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    Basic Information

    Product Code
    QLY
    Device Class
    FDA class 2
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    An Ophthalmic Syringe is a piston syringe intended for intraocular injections. The device consists of a calibrated hollow barrel, a movable plunger, and may include a needle. The device should be used by health care professionals to perform injections into the eye.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 7 510(k) clearances via K numbers.

    K Number Device Name
    K251849 StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)
    K243322 Altaviz Intravitreal Syringe
    K243027 Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27)
    K243936 StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)
    K243149 Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)
    K230372 VitreJect Syringe
    K200242 StaClear Syringe

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.