APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE

APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE is an FDA 510(k)-cleared medical device (DEN100026) manufactured by Aptus Endosystems, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 20, 2011. Regulation: 8.