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510(k) Data Aggregation

    K Number
    K203321
    Device Name
    Cystoject Syringe Lever
    Manufacturer
    UroGen Pharma Ltd
    Date Cleared
    2020-12-09

    (27 days)

    Product Code
    QBL
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    QBL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cystoject Syringe Lever Device is intended for use in the administration of sterile materials under aseptic conditions, in a clinical urology setting, by a clinician and in accordance with the best judgment of a physician.
    Device Description
    The Cystoject Syringe Lever is a reusable device that is intended for use in the delivery of sterile materials under aseptic conditions, in a clinical urology setting, by a clinician and in accordance with the best judgment of the physician. The Cystoject Syringe Lever body contains a housing for holding a standard syringe and a lever that pushes the syringe's plunger when the user rotates its knob. A clutch mechanism allows the user to quickly move the lever to the syringe plunger's position. The Cystoject Syringe Lever does not require an energy source, does not utilize electrical components, and does not utilize software or hardware. The Cystoject Syringe Lever does not come into direct or indirect contact with the patient nor with fluids intended for instillation. The Cystoject Syringe Lever is provided non-sterile as a reusable, reprocessable device to be cleaned and sterilized or high-level disinfected before each use. The Cystoject Syringe Lever indicated for use with a 30 mL syringe.
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    K Number
    K190987
    Device Name
    Uroject12 Syringe Lever
    Manufacturer
    UroGen Pharma Ltd.
    Date Cleared
    2019-12-02

    (231 days)

    Product Code
    QBL
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    QBL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Uroject 12 Syringe Lever Device is intended for use in the administration of sterile materials under aseptic conditions, in a clinical urology setting, by a clinician and in accordance with the best judgment of a physician.
    Device Description
    The Uroject12 Syringe Lever body contains syringe housing for holding a standard 20 mL syringe and a dispensing mechanism that is manually operated by rotating a knob that presses the syringe piston. A clutch mechanism facilitates fast adaptation of the injection mechanism to the syringe piston position. The Uroject12 Syringe Lever is a reusable, reprocessed device to be sterilized before each use and cleaned after use. The compatible syringes to be used with the Uroject12 are: 20 mL MEDALLION® syringe (Catalog Number MSS121, Merit Medical, Salt Lake City, UT, USA) and 20 mL MEDALLION® COP syringe (Catalog Number COP121PC, Merit Medical, Salt Lake City, UT, USA).
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    K Number
    K180345
    Device Name
    Uroject12 Syringe Lever
    Manufacturer
    UroGen Pharma Ltd.
    Date Cleared
    2018-10-17

    (251 days)

    Product Code
    QBL, MEB
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    QBL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Uroject 12 Syringe Lever Device is intended for use in the administration of sterile materials under aseptic conditions, in a clinical urology setting, by a clinician and in accordance with the best judgment of a physician.
    Device Description
    The Uroject12 Syringe Lever body contains syringe housing for holding a standard 20 mL syringe and a dispensing mechanism that is manually operated by rotating a knob that presses the syringe piston. A clutch mechanism facilitates fast adaptation of the injection mechanism to the syringe piston position. The Uroject12 Syringe Lever is a reusable, reprocessed device to be sterilized before each use and cleaned after use. The compatible syringes to be used with the Uroject12 are: 20 mL MEDALLION® syringe (Catalog Number MSS121, Merit Medical, Salt Lake City, UT, USA) and 20 mL MEDALLION® COP syringe (Catalog Number COP121PC, Merit Medical, Salt Lake City, UT, USA).
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