510(k) K122653

MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES by Kimberly-Clark Corporation — Product Code KNT

K122653 is an FDA 510(k) premarket notification submitted by Kimberly-Clark Corporation for the device "MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent (kit) on June 26, 2013. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Kimberly-Clark Corporation has at least 10 other 510(k) clearances on record.