Uroject12 Syringe Lever
K-Number: K190987 · 2019-12-02
ApplicantUrogen Pharma, Ltd.
Decision Date2019-12-02
Product CodeQBL
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Uroject12 Syringe Lever is a medical device manufactured by Urogen Pharma, Ltd.. It received FDA 510(k) clearance on 2019-12-02 under approval number K190987. The device is classified under product code QBL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Uroject12 Syringe Lever?
Uroject12 Syringe Lever is a medical device that received FDA 510(k) clearance on 2019-12-02. It is manufactured by Urogen Pharma, Ltd.. The 510(k) number is K190987.
When was Uroject12 Syringe Lever approved by the FDA?
Uroject12 Syringe Lever received FDA 510(k) clearance on 2019-12-02, under approval number K190987.
What company makes Uroject12 Syringe Lever?
Uroject12 Syringe Lever is manufactured by Urogen Pharma, Ltd..
What is the FDA product code for Uroject12 Syringe Lever?
The FDA product code for Uroject12 Syringe Lever is QBL.
Other Devices by Urogen Pharma, Ltd.
Related Devices (Code: QBL)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.