FLEXI-TRAK ANCHORING DEVICE

FLEXI-TRAK ANCHORING DEVICE is an FDA 510(k)-cleared medical device (K932143) manufactured by Convatec, A Division of E.R. Squibb & Sons. 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 November 30, 1993. Regulation: 8.