SURGI-VISION ESOPHAGEAL STYLET COIL

SURGI-VISION ESOPHAGEAL STYLET COIL is an FDA 510(k)-cleared medical device (K994436) manufactured by Surgi-Vision, 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 March 13, 2000. Regulation: 8.