510(k) K241169

Entarik NI Feeding Tube System by Gravitas Medical, Inc. — Product Code KNT

K241169 is an FDA 510(k) premarket notification submitted by Gravitas Medical, Inc. for the device "Entarik NI Feeding Tube System". The FDA issued a decision of Substantially Equivalent on November 22, 2024. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Gravitas Medical, Inc. has at least 1 other 510(k) clearance on record.