Stent, Metallic, Expandable, Duodenal
General, Plastic Surgery · 21 CFR 878.3610
Recent MDR events
991 adverse event reports on file
- WallFlex? DuodenalJul 28, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03065
- WALLFLEX? DUODENALJul 17, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02912
- EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVEREDJul 16, 2026MalfunctionCook Ireland Ltd3001845648-2026-00282
- NITI-S PYLORIC & DUODENAL UNCOVERED STENTMay 11, 2026MalfunctionTaewoong Medical Co.,ltd.3003902943-2026-00009
- WALLFLEX? DUODENALMay 7, 2026MalfunctionBoston Scientific Corporation3005099803-2026-01676
- EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVEREDMay 6, 2026MalfunctionCook Ireland Ltd3001845648-2026-00166
- NITI-S PYLORIC & DUODENAL UNCOVERED STENTApr 23, 2026MalfunctionTaewoong Medical Co.,ltd.3003902943-2026-00008
- EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVEREDDec 24, 2025MalfunctionCook Ireland Ltd3001845648-2025-00653
- EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVEREDDec 23, 2025MalfunctionCook Ireland Ltd3001845648-2025-00647
- HANAROSTENT® LOWAX¿ DUODENUM/PYLORUS (NNN)Dec 11, 2025MalfunctionM.i.tech Co., Ltd.3008146331-2025-00007
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
21 firms currently registered for this product code
Synergy Health Ast, Srl
Alajuela, CR
Boston Scientific Corporation
Marlborough, MA, US
Synergy Health Westport Ltd
Westport Mayo, IE
Boston Scientific Corporation
Coventry, RI, US
Taewoong Medical Co., Ltd
Gimpo-Si Gyeonggi, KR
M.i.tech Co., Ltd.
Seoul, KR
M.i.tech Co Ltd
Pyeongtaek Gyeonggi, KR
Synergy Health Ireland Ltd
Tullamore Offaly, IE
Cook Medical Llc
Bloomington, IN, US
M.i.tech Co., Ltd.
Jeonju Jeonbuk, KR
Cook Medical Eudc Gmbh
Baesweiler North Rhine-Westphalia, DE
Cook Ireland Ltd
LIMERICK, IE
Boston Scientific Limited
GALWAY, IE
510(k) clearances
6 clearances for this product code
- Taewoong Medical Co., Ltd.Mar 31, 2025
K250663 · Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent
- Taewoong Medical Co., Ltd.Jun 14, 2023
K223067 · Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent
- Cook Ireland, Ltd.May 4, 2017
K163468 · Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered
- Cook Ireland, Ltd.Mar 29, 2011
K101530 · EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D
- Boston Scientific CorpDec 4, 2006
K062750 · WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030
- Boston Scientific Scimed, Inc.Apr 3, 1998
K980113 · WALLSTENT ENTERAL ENDOPROSTHESIS