Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart D — Prosthetic Devices](/submissions/SU/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 878.3610](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3610) → MQR — Stent, Colonic, Metallic, Expandable

# MQR · Stent, Colonic, Metallic, Expandable

_General, Plastic Surgery · 21 CFR 878.3610 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MQR

## Overview

- **Product Code:** MQR
- **Device Name:** Stent, Colonic, Metallic, Expandable
- **Regulation:** [21 CFR 878.3610](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3610)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **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](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MQR/K234046.md) | 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](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MQR/K201159.md) | WallFlex Colonic Stent System with Anchor Lock Delivery System | Boston Scientific Corporation | Aug 17, 2020 | SESE |
| [K200257](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MQR/K200257.md) | 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](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MQR/K190141.md) | HANAROSTENT LowAx Colon/Rectum (NNN) | M.I.Tech Co., Ltd. | Mar 7, 2019 | SESE |
| [K183616](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MQR/K183616.md) | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) | M.I.Tech Co., Ltd. | Jan 10, 2019 | SESE |
| [K180180](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MQR/K180180.md) | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) | M.I.Tech Co., Ltd. | Nov 2, 2018 | SESE |
| [K113510](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MQR/K113510.md) | EVOLUTION COLONIC STENT SYSTEM | Cook Ireland, Ltd. | May 17, 2012 | SESE |
| [K061877](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MQR/K061877.md) | WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM | Boston Scientific Corp | Sep 15, 2006 | SESE |
| [K060323](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MQR/K060323.md) | ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 | Boston Scientific Corporation | May 12, 2006 | SESE |
| [K042065](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MQR/K042065.md) | WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM | Boston Scientific Corp | Sep 30, 2004 | SESE |
| [K030769](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MQR/K030769.md) | ULTRAFLEX PRECISION COLONIC STENT | Boston Scientific Corp | Jul 14, 2003 | SESE |
| [K000281](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MQR/K000281.md) | WALLSTENT ENTERNAL PROSTHESIS | Boston Scientific Corp | May 12, 2000 | SESE |
| [K990034](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MQR/K990034.md) | WILSON-COOK COLONIC Z-STENT | Med Institute, Inc. | Apr 17, 2000 | SESE |
| [K990504](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MQR/K990504.md) | MEMOTHERM COLORECTAL STENT | C.R. Bard, Inc. | Mar 16, 2000 | SESE |
| [K991056](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MQR/K991056.md) | WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM | Boston Scientific Corp | Jun 22, 1999 | SESE |
| [K954290](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MQR/K954290.md) | 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
- Boston Scientific Scimed, Inc. — 1 clearance
- C.R. Bard, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MQR](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MQR)

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