FISCH TITANIUM MIDDLE EAR PROSTHESES

FISCH TITANIUM MIDDLE EAR PROSTHESES is an FDA 510(k)-cleared medical device (K043375) manufactured by Karl Storz Endoscopy. 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 January 23, 2005. Regulation: 8.