Product code MQR
- Device name
- Stent, Colonic, Metallic, Expandable
- 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
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K234046 | WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System wit... | Boston Scientific Corporation | 2024-03-08 |
| K201159 | WallFlex Colonic Stent System with Anchor Lock Delivery System | Boston Scientific Corporation | 2020-08-17 |
| K200257 | WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System | Boston Scientific Corporation | 2020-04-17 |
| K190141 | HANAROSTENT LowAx Colon/Rectum (NNN) | M.I.Tech Co., Ltd. | 2019-03-07 |
| K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) | M.I.Tech Co., Ltd. | 2019-01-10 |
| K180180 | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) | M.I.Tech Co., Ltd. | 2018-11-02 |
| K113510 | EVOLUTION COLONIC STENT SYSTEM | Cook Ireland, Ltd. | 2012-05-17 |
| K061877 | WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM | Boston Scientific Corp | 2006-09-15 |
| K060323 | ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 | Boston Scientific Corporation | 2006-05-12 |
| K042065 | WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM | Boston Scientific Corp | 2004-09-30 |
| K030769 | ULTRAFLEX PRECISION COLONIC STENT | Boston Scientific Corp | 2003-07-14 |
| K000281 | WALLSTENT ENTERNAL PROSTHESIS | Boston Scientific Corp | 2000-05-12 |
| K990034 | WILSON-COOK COLONIC Z-STENT | Med Institute, Inc. | 2000-04-17 |
| K990504 | MEMOTHERM COLORECTAL STENT | C.R. Bard, Inc. | 2000-03-16 |
| K991056 | WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM | Boston Scientific Corp | 1999-06-22 |
| K954290 | WALLSTENT ENTERAL ENDOPROTHESIS | Boston Scientific Scimed, Inc. | 1996-07-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08806367076144 | HANAROSTENT LowAxTM Colon/Rectum(NNN) | M.I.Tech Co., Ltd. | 2018-11-20 |
| 08806367076137 | HANAROSTENT LowAxTM Colon/Rectum(NNN) | M.I.Tech Co., Ltd. | 2018-11-20 |
| 08806367076106 | HANAROSTENT LowAxTM Colon/Rectum(NNN) | M.I.Tech Co., Ltd. | 2018-11-20 |
| 08806367076076 | HANAROSTENT LowAxTM Colon/Rectum(NNN) | M.I.Tech Co., Ltd. | 2018-11-20 |
| 08714729456520 | WallFlex™ Colonic | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729456629 | WallFlex™ Colonic | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729456612 | WallFlex™ Colonic | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729456605 | WallFlex™ Colonic | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729456599 | WallFlex™ Colonic | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729456582 | WallFlex™ Colonic | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729456575 | WallFlex™ Colonic | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729456568 | WallFlex™ Colonic | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729456551 | WallFlex™ Colonic | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729456544 | WallFlex™ Colonic | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729456537 | WallFlex™ Colonic | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204633 | WALLSTENT™ BILIARY | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729456513 | WallFlex™ Colonic | 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 |
| 08714729204640 | WALLSTENT™ BILIARY | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |