Cleared Special

CORTRAK* 2 Equilateral Enteral Access System

K191340 · Avanos Medical, Inc. · Gastroenterology & Urology
Jun 2019
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K191340 is an FDA 510(k) clearance for the CORTRAK* 2 Equilateral Enteral Access System, 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 4, 2019, 15 days after receiving the submission on May 20, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K191340 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2019
Decision Date June 04, 2019
Days to Decision 15 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

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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