Clearance Summary
Uroject12 Syringe Lever received FDA 510(k) clearance under submission number K190987, sponsored by Urogen Pharma, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2019-12-02.
- Submission: K190987
- Applicant / Sponsor: Urogen Pharma, Ltd.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2019-12-02
Classification & Regulation
This clearance is catalogued under FDA product code QBL and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.