QBL
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Piston Syringe Lever
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Medical specialty
- General Hospital
- Flags
- Third-party review eligible
- FDA definition
- Controlled compression of a piston syringe
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Cystoject Syringe Lever (K203321) | Urogen Pharma, Ltd. | 2020-12-09 |
| Uroject12 Syringe Lever (K190987) | Urogen Pharma, Ltd. | 2019-12-02 |
| Uroject12 Syringe Lever (K180345) | Urogen Pharma, Ltd. | 2018-10-17 |
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Every clearance here is in the API, with alerts when new ones post.