QYM · Class II · 21 CFR 880.5570

FDA Product Code QYM: Ophthalmic Needle

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.

Leading manufacturers include Terumo Europe N.V..

1
Total
1
Cleared
197d
Avg days
2023
Since

List of Ophthalmic Needle devices cleared through 510(k)

1 devices
1–1 of 1
Cleared Oct 18, 2023
Terumo Injection Filter Needle (NF-3013RBKE05M)
K230951
Terumo Europe N.V.
General Hospital · 197d

How to use this database

This page lists all FDA 510(k) submissions for Ophthalmic Needle devices (product code QYM). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the General Hospital FDA review panel. Browse all General Hospital devices →