510(k) K230951

Terumo Injection Filter Needle (NF-3013RBKE05M) by Terumo Europe N.V. — Product Code QYM

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 18, 2023
Date Received: April 4, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Ophthalmic Needle
Device Class: Class II
Regulation Number: 880.5570
Review Panel: HO
Submission Type

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.

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K192057 — K-Pack II Needle - 27G x 1/2 Extra Thin Wall, K-Pack II Needle - 27G x 1/2 Ult (October 11, 2019)
K161606 — Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH (February 10, 2017)
K151398 — K-Pack II Needle - 29G x 5/16 Thin Wall (June 25, 2015)
K150263 — K-Pack II Needle-21G x 2 (April 1, 2015)
K133894 — SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) (March 18, 2014)
K133867 — SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) (February 5, 2014)

510(k) K230951

Clearance Details

Device Classification

Other clearances by Terumo Europe N.V.

Other clearances for product code QYM