MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R)

MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R) is an FDA 510(k)-cleared medical device (K945576) manufactured by Meadox Medicals, Div. Boston Scientific Corp.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 23, 1995. Regulation: 8.