WEHRS INCUS-STAPES

WEHRS INCUS-STAPES is an FDA 510(k)-cleared medical device (K000858) manufactured by Gyrus Ent LLC. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 2, 2000. Regulation: 8.