510(k) K003753

GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE by Uresil Corp. — Product Code FGE

K003753 is an FDA 510(k) premarket notification submitted by Uresil Corp. for the device "GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE". The FDA issued a decision of Substantially Equivalent on January 4, 2001. 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 Corp. has at least 10 other 510(k) clearances on record.