ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE

ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE is an FDA 510(k)-cleared medical device (K071903) manufactured by Vision-Sciences, 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 August 1, 2007. Regulation: 8.