KSEA MINIATURE ENDOSCOPE, MODEL 11565

KSEA MINIATURE ENDOSCOPE, MODEL 11565 is an FDA 510(k)-cleared medical device (K070752) 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 April 30, 2007. Regulation: 8.