FDA 510(k)

K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)

N.º K: K251447 · 2025-07-08

Fecha de decisión2025-07-08

Código de productoFMI

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) 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 2025-07-08 under 510(k) number K251447. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)?

K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) is a medical device that received FDA 510(k) clearance on 2025-07-08. The listed applicant is Terumo Europe N.V.. The 510(k) number is K251447.

When did K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) receive FDA 510(k) clearance?

K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) received FDA 510(k) clearance on 2025-07-08, under 510(k) number K251447.

Who is the listed applicant for K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)?

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 K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)?

The FDA product code for K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) is FMI.

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

K24330927G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)K243581K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)K230951Terumo Injection Filter Needle (NF-3013RBKE05M)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: FMI)

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.