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FDA 510(k)

FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing

N.º K: K252015 · 2026-01-28

SolicitanteKoru Medical Systems, Inc.
Fecha de decisión2026-01-28
Código de productoFRN
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Koru Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-01-28 under 510(k) number K252015. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing?

FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing is a medical device that received FDA 510(k) clearance on 2026-01-28. The listed applicant is Koru Medical Systems, Inc.. The 510(k) number is K252015.

When did FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing receive FDA 510(k) clearance?

FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing received FDA 510(k) clearance on 2026-01-28, under 510(k) number K252015.

Who is the listed applicant for FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing?

The FDA 510(k) record lists Koru Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing?

The FDA product code for FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing is FRN.

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Dispositivos relacionados (Código: FRN)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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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.

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