Disposable Needle Guides and Grids

Disposable Needle Guides and Grids is an FDA 510(k)-cleared medical device (K223689) manufactured by Advance Medical Designs, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 1, 2023. Regulation: 8.