510(k) K013172

PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL by Porges S.A. — Product Code EZL

K013172 is an FDA 510(k) premarket notification submitted by Porges S.A. for the device "PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL". The FDA issued a decision of Substantially Equivalent on December 20, 2001. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Porges S.A. has at least 10 other 510(k) clearances on record.