510(k) K072787

GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111 by Syncro Medical Innovations, Inc. — Product Code KNT

K072787 is an FDA 510(k) premarket notification submitted by Syncro Medical Innovations, Inc. for the device "GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111". The FDA issued a decision of Substantially Equivalent on October 31, 2007. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Syncro Medical Innovations, Inc. has at least 5 other 510(k) clearances on record.