{"data":{"id":"us/21-cfr-878.3610","jurisdiction":"us","citation":"21 CFR 878.3610","heading":"Esophageal prosthesis.","body":"(a) Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.\n(b) Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 878—GENERAL AND PLASTIC SURGERY DEVICES","Subpart D—Prosthetic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"52b69d78cd03c8039f7c8b98935ce9de6835a69289f0fdcfe70bf3f9394b00be","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-878.3590","next":"us/21-cfr-878.3680"},"notice":"GroundRules: Original legal text. Not legal advice."}