510(k) K190084

McLean-Ring Enteral Feeding Tube Set by Cook Incorporated — Product Code KNT

K190084 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "McLean-Ring Enteral Feeding Tube Set". The FDA issued a decision of Substantially Equivalent on October 11, 2019. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Cook Incorporated has at least 10 other 510(k) clearances on record.