Stent, Metallic, Expandable, Duodenal
A Metallic Expandable Duodenal Stent is a self-expanding metal stent placed endoscopically in the duodenum to relieve obstruction caused by malignant or benign strictures, restoring luminal patency and allowing passage of food and digestive secretions. It is classified as both an implant and FDA Class 2, requiring 510(k) clearance, with product code MUM under 21 CFR 878.3610 in the General and Plastic Surgery specialty. The device is not life-sustaining.
Basic Information
- Product Code
- MUM
- Device Class
- FDA class 2
- Regulation Number
- 878.3610
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent | Mar 31, 2025 | Substantially Equivalent | Taewoong Medical Co., Ltd. |
| K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent | Jun 14, 2023 | Substantially Equivalent | Taewoong Medical Co., Ltd. |
| K163468 | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered | May 04, 2017 | Substantially Equivalent | Cook Ireland, Ltd. |
| K101530 | EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D | Mar 29, 2011 | Substantially Equivalent | Cook Ireland, Ltd. |
| K062750 | WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 | Dec 04, 2006 | Substantially Equivalent | Boston Scientific Corp |
| K980113 | WALLSTENT ENTERAL ENDOPROSTHESIS | Apr 03, 1998 | Substantially Equivalent | Boston Scientific Scimed, Inc. |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.