510(k) K053245

GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER by Uresil, LLC — Product Code FGE

K053245 is an FDA 510(k) premarket notification submitted by Uresil, LLC for the device "GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER". The FDA issued a decision of Substantially Equivalent on December 20, 2005. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. Uresil, LLC has at least 10 other 510(k) clearances on record.