FibermarX Radiopaque Tissue Marker

FibermarX Radiopaque Tissue Marker is an FDA 510(k)-cleared medical device (K190155) manufactured by Viscus Biologics, 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 February 26, 2019. Regulation: 8.