Product code MUM
- Device name
- Stent, Metallic, Expandable, Duodenal
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.3610
- Review panel
- GU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. | 2025-03-31 |
| K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. | 2023-06-14 |
| K163468 | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered | Cook Ireland, Ltd. | 2017-05-04 |
| K101530 | EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D | Cook Ireland, Ltd. | 2011-03-29 |
| K062750 | WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 | Boston Scientific Corp | 2006-12-04 |
| K980113 | WALLSTENT ENTERAL ENDOPROSTHESIS | Boston Scientific Scimed, Inc. | 1998-04-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08806367076762 | HANAROSTENT LowAxTM Duodenum/Pylorus(NNN) | M.I.Tech Co., Ltd. | 2018-11-20 |
| 08806367076731 | HANAROSTENT LowAxTM Duodenum/Pylorus(NNN) | M.I.Tech Co., Ltd. | 2018-11-20 |
| 08806367076700 | HANAROSTENT LowAxTM Duodenum/Pylorus(NNN) | M.I.Tech Co., Ltd. | 2018-11-20 |
| 08806367076694 | HANAROSTENT LowAxTM Duodenum/Pylorus(NNN) | M.I.Tech Co., Ltd. | 2018-11-20 |
| 08806367076663 | HANAROSTENT LowAxTM Duodenum/Pylorus(NNN) | M.I.Tech Co., Ltd. | 2018-11-20 |
| 08806367076632 | HANAROSTENT LowAxTM Duodenum/Pylorus(NNN) | M.I.Tech Co., Ltd. | 2018-11-20 |
| 08806367076625 | HANAROSTENT LowAxTM Duodenum/Pylorus(NNN) | M.I.Tech Co., Ltd. | 2018-11-20 |
| 08806367076595 | HANAROSTENT LowAxTM Duodenum/Pylorus(NNN) | M.I.Tech Co., Ltd. | 2018-11-20 |
| 08806367076564 | HANAROSTENT LowAxTM Duodenum/Pylorus(NNN) | M.I.Tech Co., Ltd. | 2018-11-20 |
| 08806367076557 | HANAROSTENT LowAxTM Duodenum/Pylorus(NNN) | M.I.Tech Co., Ltd. | 2018-11-20 |
| 08806367076526 | HANAROSTENT LowAxTM Duodenum/Pylorus(NNN) | M.I.Tech Co., Ltd. | 2018-11-20 |
| 08806367076496 | HANAROSTENT LowAxTM Duodenum/Pylorus(NNN) | M.I.Tech Co., Ltd. | 2018-11-20 |
| 10827002480268 | Evolution | COOK IRELAND LTD | 2015-10-24 |
| 10827002480251 | Evolution | COOK IRELAND LTD | 2015-10-24 |
| 08714729456506 | WallFlex™ Duodenal | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204640 | WALLSTENT™ BILIARY | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729456490 | WallFlex™ Duodenal | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729456483 | WallFlex™ Duodenal | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729285144 | WALLSTENT™ Enteral Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729285137 | WALLSTENT™ Enteral Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729285120 | WALLSTENT™ Enteral Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729285113 | WALLSTENT™ Enteral Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729285083 | WALLSTENT™ Enteral Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729285076 | WALLSTENT™ Enteral Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729285069 | WALLSTENT™ Enteral Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729285052 | WALLSTENT™ Enteral Endoprosthesis | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204688 | WALLSTENT™ BILIARY | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204671 | WALLSTENT™ BILIARY | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204664 | WALLSTENT™ BILIARY | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204657 | WALLSTENT™ BILIARY | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |