KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES

KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES is an FDA 510(k)-cleared medical device (K053262) manufactured by KARL STORZ Endoscopy-America, Inc.. 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 December 18, 2005. Regulation: 8.