FDA Product Code ESW: Prosthesis, Esophageal

Esophageal stenting provides palliation for patients with malignant or benign esophageal obstruction. FDA product code ESW covers esophageal prostheses — self-expanding metal or plastic stents placed endoscopically.

These devices are deployed across esophageal strictures to maintain luminal patency and restore the ability to swallow in patients with esophageal cancer, anastomotic strictures, or tracheoesophageal fistulae.

ESW devices are Class II medical devices, regulated under 21 CFR 878.3610 and reviewed by the FDA Gastroenterology & Urology panel.

Leading manufacturers include Boston Scientific Corporation, Taewoong Medical Co., Ltd. and M.I. Tech Co., Ltd..