URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK

URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK is an FDA 510(k)-cleared medical device (K093653) manufactured by Uresil, LLC. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 22, 2010. Regulation: 8.