510(k) K010068

RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM by Rusch Intl. — Product Code ESW

K010068 is an FDA 510(k) premarket notification submitted by Rusch Intl. for the device "RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM". The FDA issued a decision of Substantially Equivalent on Feb 8, 2001. The device falls under product code ESW (Prosthesis, Esophageal), a Class II device regulated under 21 CFR 878.3610. Rusch Intl. has at least 10 other 510(k) clearances on record.