KSEA NEURO-FIBERSCOPE

KSEA NEURO-FIBERSCOPE is an FDA 510(k)-cleared medical device (K991069) 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 June 2, 1999. Regulation: 8.