510(k) K093653

URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK by Uresil, LLC — Product Code KNT

K093653 is an FDA 510(k) premarket notification submitted by Uresil, LLC for the device "URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK". The FDA issued a decision of Substantially Equivalent (kit) on February 23, 2010. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Uresil, LLC has at least 10 other 510(k) clearances on record.