510(k) K110005

SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE by Syncro Medical Innovations, Inc. — Product Code KNT

K110005 is an FDA 510(k) premarket notification submitted by Syncro Medical Innovations, Inc. for the device "SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE". The FDA issued a decision of Substantially Equivalent (kit) on August 4, 2011. 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.