Cleared Traditional

CORTRAK* 2 Enteral Access System (20-0950)

K240965 · Avanos Medical, Inc. · Gastroenterology & Urology
Jun 2024
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K240965 is an FDA 510(k) clearance for the CORTRAK* 2 Enteral Access System (20-0950), a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Avanos Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on June 6, 2024, 58 days after receiving the submission on April 9, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K240965 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 2024
Decision Date June 06, 2024
Days to Decision 58 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code KNT — Tubes, Gastrointestinal (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5980

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