RONGEUR (NEUROSURGICAL INSTRUMENTS)

RONGEUR (NEUROSURGICAL INSTRUMENTS) is an FDA 510(k)-cleared medical device (K875043) manufactured by Solway, 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 January 21, 1988. Regulation: 8.