K180345 is an FDA 510(k) clearance for the Uroject12 Syringe Lever. This device is classified as a Piston Syringe Lever (Class II - Special Controls, product code QBL).
Submitted by Urogen Pharma, Ltd. (Ra’Anana, IL). The FDA issued a Cleared decision on October 17, 2018, 251 days after receiving the submission on February 8, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 880.5860. Controlled Compression Of A Piston Syringe.
| 510(k) Number | K180345 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2018 |
| Decision Date | October 17, 2018 |
| Days to Decision | 251 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | QBL - Piston Syringe Lever |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |
| Definition | Controlled Compression Of A Piston Syringe |