MUM
6 FDA 510(k) clearances · Product code
143 daysmedian time to decision
299 days90th percentile
6clearances measured
FDA profile
- Official device name
- Stent, Metallic, Expandable, Duodenal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3610
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- Adverse events (MAUDE)
- 2020: 32 · 2021: 70 · 2022: 28 · 2023: 53 · 2024: 34 · 2025: 32
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent (K250663) | Taewoong Medical Co., Ltd. | 2025-03-31 |
| Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent (K223067) | Taewoong Medical Co., Ltd. | 2023-06-14 |
| Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered (K163468) | Cook Ireland, Ltd. | 2017-05-04 |
| EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D (K101530) | Cook Ireland, Ltd. | 2011-03-29 |
| WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 (K062750) | Boston Scientific Corp | 2006-12-04 |
| WALLSTENT ENTERAL ENDOPROSTHESIS (K980113) | Boston Scientific Scimed, Inc. | 1998-04-03 |
Track MUM automatically
Every clearance here is in the API, with alerts when new ones post.