GOUDA FRAME FOR STEREOTACTIC NEUROSURGERY

GOUDA FRAME FOR STEREOTACTIC NEUROSURGERY is an FDA 510(k)-cleared medical device (K852662) manufactured by Neurosurgical Devices, 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 August 20, 1985. Regulation: 8.