MQR — Stent, Colonic, Metallic, Expandable Class II
FDA product code MQR covers "Stent, Colonic, Metallic, Expandable", a Class II medical device regulated under 21 CFR 878.3610. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 16 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MQR
- Device Class
- Class II
- Regulation Number
- 878.3610
- Submission Type
- Review Panel
- GU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K234046 | boston scientific corporation | WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodena | March 8, 2024 |
| K201159 | boston scientific corporation | WallFlex Colonic Stent System with Anchor Lock Delivery System | August 17, 2020 |
| K200257 | boston scientific corporation | WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Du | April 17, 2020 |
| K190141 | m.i.tech co | HANAROSTENT LowAx Colon/Rectum (NNN) | March 7, 2019 |
| K183616 | m.i.tech co | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) | January 10, 2019 |
| K180180 | m.i.tech co | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NN | November 2, 2018 |
| K113510 | cook ireland | EVOLUTION COLONIC STENT SYSTEM | May 17, 2012 |
| K061877 | boston scientific | WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM | September 15, 2006 |
| K060323 | boston scientific corporation | ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 | May 12, 2006 |
| K042065 | boston scientific | WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM | September 30, 2004 |
| K030769 | boston scientific | ULTRAFLEX PRECISION COLONIC STENT | July 14, 2003 |
| K000281 | boston scientific | WALLSTENT ENTERNAL PROSTHESIS | May 12, 2000 |
| K990034 | med institute | WILSON-COOK COLONIC Z-STENT | April 17, 2000 |
| K990504 | c.r. bard | MEMOTHERM COLORECTAL STENT | March 16, 2000 |
| K991056 | boston scientific | WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM | June 22, 1999 |
| K954290 | boston scientific scimed | WALLSTENT ENTERAL ENDOPROTHESIS | July 10, 1996 |