QNS · Low Dead Space Needle, Single Lumen, Hypodermic
General Hospital · 21 CFR 880.5570 · Class 2
Overview
| Product Code | QNS |
|---|---|
| Device Name | Low Dead Space Needle, Single Lumen, Hypodermic |
| Regulation | 21 CFR 880.5570 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242956 | LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle | Ocuject, LLC | Oct 25, 2024 | SESE |
| K231734 | STERiJECT Low Dead Space, STERiJECT The Invisible Needle | Tsk Laboratory International Japan KK | Mar 8, 2024 | SESE |
| K210444 | EZ-Injec LDV Sterile Safety Needle | Poonglim Pharmatech, Inc. | Feb 16, 2021 | SESE |
Top Applicants
- Ocuject, LLC — 1 clearance
- Poonglim Pharmatech, Inc. — 1 clearance
- Tsk Laboratory International Japan KK — 1 clearance
