ACUFEX ENDOBUTTON TAPE

ACUFEX ENDOBUTTON TAPE is an FDA 510(k)-cleared medical device (K952535) manufactured by Acufex Microsurgical, 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 February 7, 1996. Regulation: 8.