MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT

MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT is an FDA 510(k)-cleared medical device (K030855) manufactured by 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 April 16, 2003. Regulation: 8.