KSEA MINIATURE NEUROENDOSCOPE

KSEA MINIATURE NEUROENDOSCOPE is an FDA 510(k)-cleared medical device (K002704) manufactured by KARL STORZ Endoscopy-America, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 2, 2000. Regulation: 8.