QYM

Ophthalmic Needle

Product code
QYM
Device name
Ophthalmic Needle
Device class
Class 2
21 CFR
21 CFR 880.5570
Medical specialty
General Hospital
Marketing pathway
510(K)
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
2 (all years; only the last 3 years are listed here)

FDA classification definition

An Ophthalmic Needle is a needle intended for intraocular injections. The device should be used by health care professionals to perform injections into the eye.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2024-10-23.

NumberDecision dateApplicantDevice nameSummary
K2420732024-10-23Tsk Laboratory International Japan KKSTERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Ne…PDF
K2309512023-10-18Terumo Europe N.V.Terumo Injection Filter Needle (NF-3013RBKE05M)PDF

2 summaries are archived here for direct download.

Official FDA classification page: QYM
Classification and pathway per current FDA publications. Data from openFDA (CC0).