510(k) K222846

AMT G-Tube Balloon Gastrostomy Feeding Device by Applied Medical Technology, Inc. — Product Code KNT

K222846 is an FDA 510(k) premarket notification submitted by Applied Medical Technology, Inc. for the device "AMT G-Tube Balloon Gastrostomy Feeding Device". The FDA issued a decision of Substantially Equivalent on December 18, 2023. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Applied Medical Technology, Inc. has at least 10 other 510(k) clearances on record.