MUM — Stent, Metallic, Expandable, Duodenal Class II
FDA Device Classification
Classification Details
- Product Code
- MUM
- Device Class
- Class II
- Regulation Number
- 878.3610
- Submission Type
- Review Panel
- GU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K250663 | taewoong medical co | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent | March 31, 2025 |
| K223067 | taewoong medical co | Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent | June 14, 2023 |
| K163468 | cook ireland | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Un | May 4, 2017 |
| K101530 | cook ireland | EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-1 | March 29, 2011 |
| K062750 | boston scientific | WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M005650 | December 4, 2006 |
| K980113 | boston scientific scimed | WALLSTENT ENTERAL ENDOPROSTHESIS | April 3, 1998 |