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FDA 510(k)

Avanos* CORTRAK* 2 Enteral Access System (EAS)

K-Number: K220588 · 2022-04-22

ApplicantAvanos Medical, Inc.
Decision Date2022-04-22
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Avanos Medical, Inc.. The 510(k) number is K220588.

When was Avanos* CORTRAK* 2 Enteral Access System (EAS) approved by the FDA?

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

What company makes Avanos* CORTRAK* 2 Enteral Access System (EAS)?

Avanos* CORTRAK* 2 Enteral Access System (EAS) is manufactured by Avanos Medical, Inc..

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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Related PubMed Literature

PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

Other Devices by Avanos Medical, Inc.

K191340CORTRAK* 2 Equilateral Enteral Access System K203066COOLIEF Cooled Radiofrequency Kit Advanced K192491Coolief Radiofrequency Generator (CRG) System K241185CORGRIP* SR NG/NI Tube Retention System K242057COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) K240965CORTRAK* 2 Enteral Access System (20-0950)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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