Stent, Colonic, Metallic, Expandable
The Metallic Expandable Colonic Stent is a general surgery implant deployed endoscopically to relieve colonic obstruction caused by malignant or benign strictures, allowing the colon lumen to remain patent for fecal passage. Classified as FDA Class 2 under 21 CFR 878.3610 in the General and Plastic Surgery specialty, it requires 510(k) premarket notification. The product code is MQR, and it carries an implant flag.
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Basic Information
- Product Code
- MQR
- Device Class
- FDA class 2
- Regulation Number
- 878.3610
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| 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 | Mar 08, 2024 | Substantially Equivalent | Boston Scientific Corporation |
| K201159 | WallFlex Colonic Stent System with Anchor Lock Delivery System | Aug 17, 2020 | Substantially Equivalent | Boston Scientific Corporation |
| K200257 | WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System | Apr 17, 2020 | Substantially Equivalent | Boston Scientific Corporation |
| K190141 | HANAROSTENT LowAx Colon/Rectum (NNN) | Mar 07, 2019 | Substantially Equivalent | M.I.Tech Co., Ltd. |
| K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) | Jan 10, 2019 | Substantially Equivalent | M.I.Tech Co., Ltd. |
| K180180 | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) | Nov 02, 2018 | Substantially Equivalent | M.I.Tech Co., Ltd. |
| K113510 | EVOLUTION COLONIC STENT SYSTEM | May 17, 2012 | Substantially Equivalent | Cook Ireland, Ltd. |
| K061877 | WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM | Sep 15, 2006 | Substantially Equivalent | Boston Scientific Corp |
| K060323 | ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 | May 12, 2006 | Substantially Equivalent | Boston Scientific Corporation |
| K042065 | WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM | Sep 30, 2004 | Substantially Equivalent | Boston Scientific Corp |
| K030769 | ULTRAFLEX PRECISION COLONIC STENT | Jul 14, 2003 | Substantially Equivalent | Boston Scientific Corp |
| K000281 | WALLSTENT ENTERNAL PROSTHESIS | May 12, 2000 | Substantially Equivalent | Boston Scientific Corp |
| K990034 | WILSON-COOK COLONIC Z-STENT | Apr 17, 2000 | Substantially Equivalent | Med Institute, Inc. |
| K990504 | MEMOTHERM COLORECTAL STENT | Mar 16, 2000 | Substantially Equivalent | C.R. Bard, Inc. |
| K991056 | WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM | Jun 22, 1999 | Substantially Equivalent | Boston Scientific Corp |
| K954290 | WALLSTENT ENTERAL ENDOPROTHESIS | Jul 10, 1996 | Substantially Equivalent | Boston Scientific Scimed, Inc. |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.