PUR · Vacuum Syringe
General Hospital · 21 CFR 880.5860 · Class 2
Overview
| Product Code | PUR |
|---|---|
| Device Name | Vacuum 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 |
|---|---|---|---|---|
| K233069 | Removal System Large Bore 60 cc Syringe | Inari Medical, Inc. | Mar 26, 2024 | SESE |
| K163597 | VacLok AT Vacuum Syringe | Merit Medical Systems, Inc. | Jul 27, 2017 | SESE |
Top Applicants
- Inari Medical, Inc. — 1 clearance
- Merit Medical Systems, Inc. — 1 clearance
