QBL · Piston Syringe Lever
General Hospital · 21 CFR 880.5860 · Class 2
Overview
| Product Code | QBL |
|---|---|
| Device Name | Piston Syringe Lever |
| Regulation | 21 CFR 880.5860 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K203321 | Cystoject Syringe Lever | Urogen Pharma, Ltd. | Dec 9, 2020 | SESE |
| K190987 | Uroject12 Syringe Lever | Urogen Pharma, Ltd. | Dec 2, 2019 | SESE |
| K180345 | Uroject12 Syringe Lever | Urogen Pharma, Ltd. | Oct 17, 2018 | SESE |
Top Applicants
- Urogen Pharma, Ltd. — 3 clearances
