510(k) K191340

CORTRAK* 2 Equilateral Enteral Access System by Avanos Medical, Inc. — Product Code KNT

K191340 is an FDA 510(k) premarket notification submitted by Avanos Medical, Inc. for the device "CORTRAK* 2 Equilateral Enteral Access System". The FDA issued a decision of Substantially Equivalent on June 4, 2019. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Avanos Medical, Inc. has at least 7 other 510(k) clearances on record.