PVZ · Non-Stainless Steel Needle
General Hospital · 21 CFR 880.5570 · Class 2
Overview
| Product Code | PVZ |
|---|---|
| Device Name | Non-Stainless Steel Needle |
| Regulation | 21 CFR 880.5570 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K163437 | hypodermic Pinpoint GT Needle | C.R. Bard, Inc. | Jun 23, 2017 | SESE |
Top Applicants
- C.R. Bard, Inc. — 1 clearance
