510(k) K123659

TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR) by Actuated Medical, Inc. — Product Code KNT

K123659 is an FDA 510(k) premarket notification submitted by Actuated Medical, Inc. for the device "TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR)". The FDA issued a decision of Substantially Equivalent on December 20, 2012. 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.