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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
UroGen Pharma Ltd.
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
K180354Device Name
UroGen Ureteral Catheter
Manufacturer
UroGen Pharma Ltd.
Date Cleared
2018-10-30
(264 days)
Product Code
KOD, GBM
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
UroGen Pharma Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UroGen Ureteral Catheter is indicated for use by physicians for facilitating access to the urinary tract through a retrograde route and may be used in conjunction with a guidewire or for the injection of gels or fluids into the urinary tract.
Device Description
The device is a single use ureteral catheter, designed to assist in access to the upper urinary tract using standard endoscopic technique for drainage and delivery of gels or fluids. The catheter is indicated for use by physicians for facilitating access to the urinary tract through a retrograde route and may be used in conjunction with a guidewire or for the injection of gels or fluids into the urinary tract.
The catheter is supplied sterile in a Tyvek pouch with a sterilization indicator. The catheter is inserted into the body for a typical duration of less than 1 hour. The catheter is placed over a guidewire of up to 0.038 inches in diameter that is prepositioned through the urological tract.
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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?
Applicant Name (Manufacturer) :
UroGen Pharma Ltd.
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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