Business · 26/11/2025Updated: 10/17/2026 · 1 min read
FDA Classifies Anchored Esophageal Sheath as Class II Device with Special Controls
The FDA has classified the anchored esophageal sheath as a Class II device with special controls, aiming to ensure safety and effectiveness while reducing regulatory burdens and enhancing patient access to innovative devices.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →