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, Boston Scientific and Merit Medical Systems, Inc..
List of Prosthesis, Esophageal devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Prosthesis, Esophageal devices (product code ESW). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Gastroenterology & Urology FDA review panel. Browse all Gastroenterology & Urology devices →