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, Merit Medical Systems, Inc. and M.I. Tech Co., Ltd..
FDA 510(k) Cleared Prosthesis, Esophageal Devices (Product Code ESW)
About Product Code ESW - Regulatory Context
510(k) Submission Activity
59 total 510(k) submissions under product code ESW since 1987, with 59 receiving FDA clearance (average review time: 165 days).
Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 5 in the prior period.
FDA Review Time
FDA review times for ESW submissions have been consistent, averaging 154 days recently vs 166 days historically.
ESW devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →