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510(k) Data Aggregation
K Number
K203321Device Name
Cystoject Syringe Lever
Manufacturer
UroGen Pharma Ltd
Date Cleared
2020-12-09
(27 days)
Product Code
QBL
Regulation Number
880.5860Why 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
K190987Device Name
Uroject12 Syringe Lever
Manufacturer
UroGen Pharma Ltd.
Date Cleared
2019-12-02
(231 days)
Product Code
QBL
Regulation Number
880.5860Why 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
K180345Device Name
Uroject12 Syringe Lever
Manufacturer
UroGen Pharma Ltd.
Date Cleared
2018-10-17
(251 days)
Product Code
QBL, MEB
Regulation Number
880.5860Why 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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