PQX · Epinephrine Syringe
General Hospital · 21 CFR 880.5860 · Class 2
Overview
| Product Code | PQX |
|---|---|
| Device Name | Epinephrine Syringe |
| 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K180683 | Certa Dose Pediatric Midazolam 5mg/mL IM Syringe | Certa Dose, Inc. | Nov 7, 2018 | SESE |
| K160589 | Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe | Certa Dose, Inc. | Jan 19, 2017 | SESE |
Top Applicants
- Certa Dose, Inc. — 2 clearances
