Stent, Colonic, Metallic, Expandable
FDA product code MQR · Class II (moderate risk) · 21 CFR 878.3610 · General, Plastic Surgery
16510(k) clearances
0PMA approvals
2recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K234046 | WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent…MQR · Special | Boston Scientific Corporation | 03/08/2024SE |
| K201159 | WallFlex Colonic Stent System with Anchor Lock Delivery SystemMQR · Traditional | Boston Scientific Corporation | 08/17/2020SE |
| K200257 | WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal…MQR · Traditional | Boston Scientific Corporation | 04/17/2020SE |
| K190141 | HANAROSTENT LowAx Colon/Rectum (NNN)MQR · Special | M.I.Tech Co., Ltd. | 03/07/2019SE |
| K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)MQR · Traditional | M.I.Tech Co., Ltd. | 01/10/2019SE |
| K180180 | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)MQR · Traditional | M.I.Tech Co., Ltd. | 11/02/2018SE |
| K113510 | Evolution Colonic Stent SystemMQR · Traditional | Cook Ireland, Ltd. | 05/17/2012SE |
| K061877 | Wallflex Enteral Colonic Stent with Anchor Lock Delivery SystemMQR · Traditional | Boston Scientific Corp | 09/15/2006SE |
| K060323 | Ultraflex Precision Colonic Stent, Models M00557330, MO00557360, M00557380MQR · Traditional | Boston Scientific Corporation | 05/12/2006SE |
| K042065 | Wallflex Enternal Colonic Stent and Anchor Lock Delivery SystemMQR · Traditional | Boston Scientific Corp | 09/30/2004SE |
| K030769 | Ultraflex Precision Colonic StentMQR · Traditional | Boston Scientific Corp | 07/14/2003SE |
| K000281 | Wallstent Enternal ProsthesisMQR · Traditional | Boston Scientific Corp | 05/12/2000SE |
| K990034 | Wilson-Cook Colonic Z-StentMQR · Traditional | Med Institute, Inc. | 04/17/2000SE |
| K990504 | Memotherm Colorectal StentMQR · Traditional | C.R. Bard, Inc. | 03/16/2000SE |
| K991056 | Wallstent Enteral Endoprosthesis with Unistep Delivery SystemMQR · Traditional | Boston Scientific Corp | 06/22/1999SE |
| K954290 | Wallstent Enteral EndoprothesisMQR · Traditional | Boston Scientific Scimed, Inc. | 07/10/1996SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3038-2018 Class II | Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM…The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization… | SPS Sterilization, Inc | 03/07/2018Terminated |
| Z-2331-2010 | Boston Scientific Ultraflex Precision Colonic Stent System Material/UPN/Catalog Number:…Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a… | Boston Scientific Corporation | 07/15/2010Terminated |