510(k) K131052

TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS) by Actuated Medical, Inc. — Product Code KNT

K131052 is an FDA 510(k) premarket notification submitted by Actuated Medical, Inc. for the device "TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)". The FDA issued a decision of Substantially Equivalent on August 16, 2013. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Actuated Medical, Inc. has at least 9 other 510(k) clearances on record.