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510(k) Data Aggregation

    K Number
    K243322
    Device Name
    Altaviz Intravitreal Syringe
    Manufacturer
    Altaviz, LLC
    Date Cleared
    2025-05-09

    (198 days)

    Product Code
    QLY, FMF
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    QLY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Altaviz Intravitreal Syringe is intended for use by heath care professionals for general purpose fluid aspiration/injection. It is indicated for general and intravitreal use in adult patients.
    Device Description
    The Altaviz Intravitreal Syringe is a three-piece sterile, single use, hypodermic syringe with male 6% (Luer) conical lock fittings, which are connectable to a compatible female 6% (Luer) connector. The syringe assembly consists of a lubricated polycarbonate barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The barrel scale of the Altaviz Intravitreal Syringe incorporates a scale graduated in units of milliliters and is provided sterile by an irradiation sterilization method. The only difference between the Altaviz Intravitreal Syringe and the BD 1mL Luer-Lok Syringe is that the Altaviz Intravitreal Syringe is routinely tested to, and must meet, additional requirements to support intraocular use including endotoxin and particulate matter. The Altaviz Intravitreal Syringe is provided sterile by irradiation sterilization.
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    K Number
    K243027
    Device Name
    Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27)
    Manufacturer
    Hangzhou Sightnovo Medical Technology Co., Ltd.
    Date Cleared
    2025-04-08

    (193 days)

    Product Code
    QLY, FMF, FMI
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    QLY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is intended for use by health care professionals for puncture, drainage and fluid collection of the anterior chamber of the eye. Its operation is manual. The Disposable Aqueous Humor Collector is single use only. The Disposable Aqueous Humor Collector is suitable for ophthalmic use.
    Device Description
    Disposable aqueous humor collector is composed of a liquid collecting needle sheath, a liquid collecting needle, a needle seat, a liquid collecting needle rubber sheath, a rubber plug, a liquid collecting tube, a cylinder body, a rubber ring, push rod and buckle structure. Models: SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27 Volume: 50μL, 100μL Needle Gauge: 25G, 27G
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    K Number
    K243936
    Device Name
    StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)
    Manufacturer
    StaClear, INC.
    Date Cleared
    2025-04-03

    (104 days)

    Product Code
    QLY, FMF, FMI
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    QLY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The StaClear Syringe is intended to inject fluids into, or withdraw fluids from, the body. The StaClear Syringe is indicated for intravitreal use.
    Device Description
    The StaClear Syringe is a single-use piston syringe intended for use by healthcare professionals for general-purpose fluid aspiration/injection. Its operation is manual. The StaClear Syringe is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. It uses standard syringe components with a low-particulate gas plasma crosslinked silicone coating called TriboLink-Si. The StaClear Syringe is suitable for ophthalmic use. The StaClear Syringe is offered in the following configurations: - SC250AN – Consisting of a 0.25 mL graduated barrel, plunger, plunger stopper, needle, needle shield, and plunger cap. - SC250LS – Consisting of a 0.25 mL graduated barrel with an ISO 80369-7-compliant luer-slip connector, plunger, and plunger stopper. - SC250LL – Consisting of a 0.25 mL graduated barrel with an ISO 80369-7-compliant luer-lock connector, plunger, and plunger stopper.
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    K Number
    K243149
    Device Name
    Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)
    Manufacturer
    Congruence Medical Solutions, LLC
    Date Cleared
    2024-12-20

    (81 days)

    Product Code
    QLY, FMF
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    QLY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microliter Dosing Syringe is intended to inject fluid into, or withdraw fluid from the body. The Microliter Dosing Syringe is indicated for intravitreal use.
    Device Description
    The Microliter Dosing Syringe is a single-use, piston syringe-based device consisting of a syringe barrel, plunger stopper, syringe tip cap and incorporates a plunger rod subassembly. It is intended for use by healthcare professionals for general purpose fluid aspiration/injection. Its operation is manual. The Microliter Dosing Syringe is single use only, non-toxic, non-pyrogenic and sterilized by e-beam irradiation. The Microliter Dosing Syringe is suitable for ophthalmic use.
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    K Number
    K230372
    Device Name
    VitreJect Syringe
    Manufacturer
    OcuJect, LLC
    Date Cleared
    2023-09-08

    (207 days)

    Product Code
    QLY, FMF, QNQ
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    QLY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VitreJect Syringe is intended to inject fluids into, or withdraw fluids from, the body. The VitreJect Syringe is indicated for intracameral and intravitreal use.
    Device Description
    The Vitrelect Syringe is designed to provide a means of fluid injection and aspiration. It is a luer-tip piston syringe consisting of a 1 mL hollow barrel with gradient markings and a plunger with an incorporated plunger stopper. The VitreJect Syringe barrel component is available in two configurations, a luer-slip or luer-lock tip, for the fitting of a compatible hypodermic needle. The VitreJect Syringe plunger is available in two configurations: standard dead space or low dead space. It is intended for manual use by health care professionals. The VitreJect Syringe is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The VitreJect Syringe is suitable for ophthalmic use.
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    K Number
    K200242
    Device Name
    StaClear Syringe
    Manufacturer
    TriboFilm Research, Inc.
    Date Cleared
    2020-07-27

    (178 days)

    Product Code
    QLY, FMF, FMI
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    QLY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The StaClear Syringe is intended to inject fluids into, or withdraw fluids from, the body. The StaClear Syringe is indicated for intravitreal use.
    Device Description
    The StaClear Syringe is a single-use piston syringe consisting of a 0.25 mL graduated barrel, plunger, plunger stopper, needle, needle shield, and plunger cap. The needle is a 31-gauge needle, 5/16in in length, which is permanently attached to the syringe body. It is intended for use by health care professionals for general purpose fluid aspiration/injection. Its operation is manual. The StaClear syringe is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear syringe is suitable for ophthalmic use.
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