DANEKSCOPE OPTI-PROBE

DANEKSCOPE OPTI-PROBE is an FDA 510(k)-cleared medical device (K943676) manufactured by Danek Medical, 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 November 20, 1994. Regulation: 8.