510(k) K190987
K190987 is an FDA 510(k) premarket notification submitted by Urogen Pharma, Ltd. for the device "Uroject12 Syringe Lever". The FDA issued a decision of Substantially Equivalent on December 2, 2019. The device falls under product code QBL (Piston Syringe Lever), a Class II device regulated under 21 CFR 880.5860. Urogen Pharma, Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 2019
- Date Received
- April 15, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Piston Syringe Lever
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type
Controlled compression of a piston syringe