NSC · Injector, Pen
General Hospital · 21 CFR 880.5860 · Class 2
Overview
| Product Code | NSC |
|---|---|
| Device Name | Injector, Pen |
| Regulation | 21 CFR 880.5860 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K063151 | HUMAPEN LUXURA HD | Eli Lilly and Co. | Jan 9, 2007 | SESE |
Top Applicants
- Eli Lilly and Co. — 1 clearance
