QYM · Ophthalmic Needle
General Hospital · 21 CFR 880.5570 · Class 2
Overview
| Product Code | QYM |
|---|---|
| Device Name | Ophthalmic Needle |
| 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242073 | STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) | Tsk Laboratory International Japan KK | Oct 23, 2024 | SESE |
| K230951 | Terumo Injection Filter Needle (NF-3013RBKE05M) | Terumo Europe N.V. | Oct 18, 2023 | SESE |
Top Applicants
- Terumo Europe N.V. — 1 clearance
- Tsk Laboratory International Japan KK — 1 clearance
