FDA Product Code
FDA Product Code QBL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5860
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K203321 | Cystoject Syringe Lever | Urogen Pharma, Ltd. | 2020-12-09 | Special | PDF ↗ |
| K190987 | Uroject12 Syringe Lever | Urogen Pharma, Ltd. | 2019-12-02 | Special | PDF ↗ |
| K180345 | Uroject12 Syringe Lever | Urogen Pharma, Ltd. | 2018-10-17 | Traditional | PDF ↗ |
Product code QBL · Class II · General Hospital. Data: openFDA.