Uroject12 Syringe Lever
FDA 510(k) clearance K180345 · decided 2018-10-17
Clearance details
- K-number
- K180345
- Device name
- Uroject12 Syringe Lever
- Applicant
- Urogen Pharma, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-02-08
- Decision date
- 2018-10-17
- Days to decision
- 251 days
- Clearance type
- Traditional
- Product code
- QBL
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- RaAnana, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Cystoject Syringe Lever (K203321) | Urogen Pharma, Ltd. | 2020-12-09 |
| Uroject12 Syringe Lever (K190987) | Urogen Pharma, Ltd. | 2019-12-02 |
Recalls involving this device
No recalls on record reference this clearance.