510(k) K093312

KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM by Kimberly-Clark Corp. — Product Code KGC

K093312 is an FDA 510(k) premarket notification submitted by Kimberly-Clark Corp. for the device "KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM". The FDA issued a decision of Substantially Equivalent on December 8, 2009. The device falls under product code KGC (Tube, Gastro-Enterostomy), a Class II device regulated under 21 CFR 876.5980. Kimberly-Clark Corp. has at least 10 other 510(k) clearances on record.