FDA 510(k)

Terumo Injection Filter Needle (NF-3013RBKE05M)

N.º K: K230951 · 2023-10-18

Fecha de decisión2023-10-18

Código de productoQYM

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Terumo Injection Filter Needle (NF-3013RBKE05M) is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Europe N.V.. It received FDA 510(k) clearance on 2023-10-18 under 510(k) number K230951. The device is classified under product code QYM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Terumo Injection Filter Needle (NF-3013RBKE05M)?

Terumo Injection Filter Needle (NF-3013RBKE05M) is a medical device that received FDA 510(k) clearance on 2023-10-18. The listed applicant is Terumo Europe N.V.. The 510(k) number is K230951.

When did Terumo Injection Filter Needle (NF-3013RBKE05M) receive FDA 510(k) clearance?

Terumo Injection Filter Needle (NF-3013RBKE05M) received FDA 510(k) clearance on 2023-10-18, under 510(k) number K230951.

Who is the listed applicant for Terumo Injection Filter Needle (NF-3013RBKE05M)?

The FDA 510(k) record lists Terumo Europe N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Terumo Injection Filter Needle (NF-3013RBKE05M)?

The FDA product code for Terumo Injection Filter Needle (NF-3013RBKE05M) is QYM.

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Otros registros que enlistan a Terumo Europe N.V. como solicitante

K251447K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)K24330927G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)K243581K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)K212095SurGuard3 Safety Hypodermic Needle K192057K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin Wall K161606Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH

Ver todos los 7 dispositivos →

Dispositivos relacionados (Código: QYM)

K242073STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)Tsk Laboratory International Japan KK

Fuente oficial

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