ETHICON LINX® Esophagus Sizing Tool

ETHICON LINX® Esophagus Sizing Tool is an FDA 510(k)-cleared medical device (K230089) 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 February 8, 2023. Regulation: 8.