MQR · Stent, Colonic, Metallic, Expandable
General, Plastic Surgery · 21 CFR 878.3610 · Class 2
Overview
| Product Code | MQR |
|---|---|
| Device Name | Stent, Colonic, Metallic, Expandable |
| Regulation | 21 CFR 878.3610 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.
Classification Rationale
Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”
Special Controls
The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”
Recent Cleared Devices (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| 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 | Mar 8, 2024 | SESE |
| K201159 | WallFlex Colonic Stent System with Anchor Lock Delivery System | Boston Scientific Corporation | Aug 17, 2020 | SESE |
| K200257 | WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System | Boston Scientific Corporation | Apr 17, 2020 | SESE |
| K190141 | HANAROSTENT LowAx Colon/Rectum (NNN) | M.I.Tech Co., Ltd. | Mar 7, 2019 | SESE |
| K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) | M.I.Tech Co., Ltd. | Jan 10, 2019 | SESE |
| K180180 | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) | M.I.Tech Co., Ltd. | Nov 2, 2018 | SESE |
| K113510 | EVOLUTION COLONIC STENT SYSTEM | Cook Ireland, Ltd. | May 17, 2012 | SESE |
| K061877 | WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM | Boston Scientific Corp | Sep 15, 2006 | SESE |
| K060323 | ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 | Boston Scientific Corporation | May 12, 2006 | SESE |
| K042065 | WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM | Boston Scientific Corp | Sep 30, 2004 | SESE |
| K030769 | ULTRAFLEX PRECISION COLONIC STENT | Boston Scientific Corp | Jul 14, 2003 | SESE |
| K000281 | WALLSTENT ENTERNAL PROSTHESIS | Boston Scientific Corp | May 12, 2000 | SESE |
| K990034 | WILSON-COOK COLONIC Z-STENT | Med Institute, Inc. | Apr 17, 2000 | SESE |
| K990504 | MEMOTHERM COLORECTAL STENT | C.R. Bard, Inc. | Mar 16, 2000 | SESE |
| K991056 | WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM | Boston Scientific Corp | Jun 22, 1999 | SESE |
| K954290 | WALLSTENT ENTERAL ENDOPROTHESIS | Boston Scientific Scimed, Inc. | Jul 10, 1996 | SESE |
Top Applicants
- Boston Scientific Corp — 5 clearances
- Boston Scientific Corporation — 4 clearances
- M.I.Tech Co., Ltd. — 3 clearances
- Med Institute, Inc. — 1 clearance
- Cook Ireland, Ltd. — 1 clearance
