510(k) K972583

URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S by Uresil Corp. — Product Code FGE

K972583 is an FDA 510(k) premarket notification submitted by Uresil Corp. for the device "URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S". The FDA issued a decision of Substantially Equivalent on August 29, 1997. 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.