MUM · Stent, Metallic, Expandable, Duodenal
General, Plastic Surgery · 21 CFR 878.3610 · Class 2
Overview
| Product Code | MUM |
|---|---|
| Device Name | Stent, Metallic, Expandable, Duodenal |
| Regulation | 21 CFR 878.3610 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
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.”
Special Controls
The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. | Mar 31, 2025 | SESE |
| K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. | Jun 14, 2023 | SESE |
| K163468 | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered | Cook Ireland, Ltd. | May 4, 2017 | SESE |
| K101530 | EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D | Cook Ireland, Ltd. | Mar 29, 2011 | SESE |
| K062750 | WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 | Boston Scientific Corp | Dec 4, 2006 | SESE |
| K980113 | WALLSTENT ENTERAL ENDOPROSTHESIS | Boston Scientific Scimed, Inc. | Apr 3, 1998 | SESE |
Top Applicants
- Taewoong Medical Co., Ltd. — 2 clearances
- Cook Ireland, Ltd. — 2 clearances
- Boston Scientific Scimed, Inc. — 1 clearance
- Boston Scientific Corp — 1 clearance
