FDA 510(k)

Avanos* CORTRAK* 2 Enteral Access System (EAS)

N.º K: K220588 · 2022-04-22

Fecha de decisión2022-04-22

Código de productoKNT

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Avanos* CORTRAK* 2 Enteral Access System (EAS) is the device name listed in this FDA 510(k) record. The listed applicant is Avanos Medical, Inc.. It received FDA 510(k) clearance on 2022-04-22 under 510(k) number K220588. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Avanos* CORTRAK* 2 Enteral Access System (EAS)?

Avanos* CORTRAK* 2 Enteral Access System (EAS) is a medical device that received FDA 510(k) clearance on 2022-04-22. The listed applicant is Avanos Medical, Inc.. The 510(k) number is K220588.

When did Avanos* CORTRAK* 2 Enteral Access System (EAS) receive FDA 510(k) clearance?

Avanos* CORTRAK* 2 Enteral Access System (EAS) received FDA 510(k) clearance on 2022-04-22, under 510(k) number K220588.

Who is the listed applicant for Avanos* CORTRAK* 2 Enteral Access System (EAS)?

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

What is the FDA product code for Avanos* CORTRAK* 2 Enteral Access System (EAS)?

The FDA product code for Avanos* CORTRAK* 2 Enteral Access System (EAS) is KNT.

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Fuente oficial

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