FDA 510(k)

CORTRAK* 2 Enteral Access System (20-0950)

Numéro K : K240965 · 2024-06-06

Date de décision2024-06-06

Code produitKNT

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

CORTRAK* 2 Enteral Access System (20-0950) 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 2024-06-06 under 510(k) number K240965. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the CORTRAK* 2 Enteral Access System (20-0950)?

CORTRAK* 2 Enteral Access System (20-0950) is a medical device that received FDA 510(k) clearance on 2024-06-06. The listed applicant is Avanos Medical, Inc.. The 510(k) number is K240965.

When did CORTRAK* 2 Enteral Access System (20-0950) receive FDA 510(k) clearance?

CORTRAK* 2 Enteral Access System (20-0950) received FDA 510(k) clearance on 2024-06-06, under 510(k) number K240965.

Who is the listed applicant for CORTRAK* 2 Enteral Access System (20-0950)?

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 CORTRAK* 2 Enteral Access System (20-0950)?

The FDA product code for CORTRAK* 2 Enteral Access System (20-0950) is KNT.

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Source officielle

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