ACUFEX ARTHROSCOPIC DISCECTOMY SYSTEMS

ACUFEX ARTHROSCOPIC DISCECTOMY SYSTEMS is an FDA 510(k)-cleared medical device (K941709) manufactured by Acufex Microsurgical, 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 April 13, 1995. Regulation: 8.