Cleared Traditional

Terumo Injection Filter Needle (NF-3013RBKE05M)

K230951 · Terumo Europe N.V. · General Hospital

Oct 2023

Decision

197d

Days

Class 2

Risk

About This 510(k) Submission

K230951 is an FDA 510(k) clearance for the Terumo Injection Filter Needle (NF-3013RBKE05M), a Ophthalmic Needle (Class II — Special Controls, product code QYM), submitted by Terumo Europe N.V. (Leuven, BE). The FDA issued a Cleared decision on October 18, 2023, 197 days after receiving the submission on April 4, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K230951 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 04, 2023
Decision Date	October 18, 2023
Days to Decision	197 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	QYM — Ophthalmic Needle
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5570
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.