ETHICON Linx Esophagus Sizing Tool

ETHICON Linx Esophagus Sizing Tool is an FDA 510(k)-cleared medical device (K201035) manufactured by Torax Medical, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 8, 2020. Regulation: 8.