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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    StaClear, INC.

    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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