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FDA 510(k)

CORTRAK* 2 Enteral Access System (20-0950)

K-Number: K240965 · 2024-06-06

ApplicantAvanos Medical, Inc.
Decision Date2024-06-06
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CORTRAK* 2 Enteral Access System (20-0950) is a medical device manufactured by Avanos Medical, Inc.. It received FDA 510(k) clearance on 2024-06-06 under approval number K240965. 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 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. It is manufactured by Avanos Medical, Inc.. The 510(k) number is K240965.

When was CORTRAK* 2 Enteral Access System (20-0950) approved by the FDA?

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

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

CORTRAK* 2 Enteral Access System (20-0950) is manufactured by Avanos Medical, Inc..

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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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 K220588Avanos* CORTRAK* 2 Enteral Access System (EAS) K241185CORGRIP* SR NG/NI Tube Retention System K242057COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)

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Related Devices (Code: KNT)

K163092TubeClear Control Box and Clearing StemActuated Medical, Inc. K162110CORGRIP NG/NI Tube Retention SystemCorpak Medsystems, Inc. A Division of Haylard Health K160787Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with StyletSyncro Medical Innovations, Inc. K152246Aquarius Stoma Measuring DeviceDegania Silicone , Ltd. K153506Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management KitConsure Medical Pvt , Ltd. K160654GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)Covidien, LLC

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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