K203321 is an FDA 510(k) clearance for the Cystoject 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 December 9, 2020, 27 days after receiving the submission on November 12, 2020.
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 | K203321 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2020 |
| Decision Date | December 09, 2020 |
| Days to Decision | 27 days |
| Submission Type | Special |
| 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 |