510(k) K130611

ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE by Xeridiem Medical Devices — Product Code KNT

K130611 is an FDA 510(k) premarket notification submitted by Xeridiem Medical Devices for the device "ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE". The FDA issued a decision of Substantially Equivalent on Dec 19, 2013. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Xeridiem Medical Devices has 2 other 510(k) clearances on record.