STELLAR FIDUCIAL MARKER, MODEL GFMIA

STELLAR FIDUCIAL MARKER, MODEL GFMIA is an FDA 510(k)-cleared medical device (K092041) manufactured by Stellar Medical, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 1, 2009. Regulation: 8.