CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX

CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX is an FDA 510(k)-cleared medical device (K960915) manufactured by Clarus Medical Systems, 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 December 23, 1996. Regulation: 8.