FDA Product Code
FDA Product Code MQR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3610
510(k) Clearances — 16 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| 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 with Anchor Lock Delivery System | Boston Scientific Corporation | 2024-03-08 | Special | PDF ↗ |
| K201159 | WallFlex Colonic Stent System with Anchor Lock Delivery System | Boston Scientific Corporation | 2020-08-17 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K190141 | HANAROSTENT LowAx Colon/Rectum (NNN) | M.I.Tech Co., Ltd. | 2019-03-07 | Special | PDF ↗ |
| K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) | M.I.Tech Co., Ltd. | 2019-01-10 | Traditional | PDF ↗ |
| K180180 | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) | M.I.Tech Co., Ltd. | 2018-11-02 | Traditional | PDF ↗ |
| K113510 | EVOLUTION COLONIC STENT SYSTEM | Cook Ireland, Ltd. | 2012-05-17 | Traditional | PDF ↗ |
| K061877 | WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM | Boston Scientific Corp | 2006-09-15 | Traditional | PDF ↗ |
| K060323 | ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 | Boston Scientific Corporation | 2006-05-12 | Traditional | PDF ↗ |
| K042065 | WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM | Boston Scientific Corp | 2004-09-30 | Traditional | PDF ↗ |
| K030769 | ULTRAFLEX PRECISION COLONIC STENT | Boston Scientific Corp | 2003-07-14 | Traditional | PDF ↗ |
| K000281 | WALLSTENT ENTERNAL PROSTHESIS | Boston Scientific Corp | 2000-05-12 | Traditional | PDF ↗ |
| K990034 | WILSON-COOK COLONIC Z-STENT | Med Institute, Inc. | 2000-04-17 | Traditional | PDF ↗ |
| K990504 | MEMOTHERM COLORECTAL STENT | C.R. Bard, Inc. | 2000-03-16 | Traditional | PDF ↗ |
| K991056 | WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM | Boston Scientific Corp | 1999-06-22 | Traditional | PDF ↗ |
| K954290 | WALLSTENT ENTERAL ENDOPROTHESIS | Boston Scientific Scimed, Inc. | 1996-07-10 | Traditional | PDF ↗ |
Product code MQR · Class II · General, Plastic Surgery. Data: openFDA.