21 CFR 878.3610 — Prosthesis, Esophageal
General, Plastic Surgery (SU) · Part 878 Subpart D—Prosthetic Devices · § 878.3610
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.
Classification Rationale
Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ESW | Prosthesis, Esophageal | 2 | 59 | Implant |
| JCQ | Prosthesis, Esophagus | 2 | 1 | Implant |
| MQR | Stent, Colonic, Metallic, Expandable | 2 | 16 | Implant |
| MUM | Stent, Metallic, Expandable, Duodenal | 2 | 6 | Implant |
Special Controls
ESW — Prosthesis, Esophageal
The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”
Ecfr Llm
