POLY-OP (TM)

POLY-OP (TM) is an FDA 510(k)-cleared medical device (K900759) manufactured by Nu-Gyn-Tek, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 23, 1990. Regulation: 8.