GORE SMOOTHER II AND GORE BPTB

GORE SMOOTHER II AND GORE BPTB is an FDA 510(k)-cleared medical device (K941269) manufactured by W. L. Gore & Associates, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 18, 1994. Regulation: 8.