Stent, Metallic, Expandable, Duodenal
FDA product code MUM · Class II (moderate risk) · 21 CFR 878.3610 · General, Plastic Surgery
6510(k) clearances
0PMA approvals
0recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort StentMUM · Special | Taewoong Medical Co., Ltd. | 03/31/2025SE |
| K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort StentMUM · Traditional | Taewoong Medical Co., Ltd. | 06/14/2023SE |
| K163468 | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - UncoveredMUM · Traditional | Cook Ireland, Ltd. | 05/04/2017SE |
| K101530 | Evolution Duodenal Stent System, Model EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-DMUM · Traditional | Cook Ireland, Ltd. | 03/29/2011SE |
| K062750 | Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System, Models M00565010…MUM · Traditional | Boston Scientific Corp | 12/04/2006SE |
| K980113 | Wallstent Enteral EndoprosthesisMUM · Traditional | Boston Scientific Scimed, Inc. | 04/03/1998SE |