PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER

PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER is an FDA 510(k)-cleared medical device (K961853) 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 June 20, 1996. Regulation: 8.