MACROPORE SURGIWRAP (TS)

MACROPORE SURGIWRAP (TS) is an FDA 510(k)-cleared medical device (K012025) manufactured by Macropore Biosurgery, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 2, 2001. Regulation: 8.