510(k) K200257
- Device
- WallFlex Colonic Soft Stent System With Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System With Anchor Lock Delivery System
- Applicant
- Boston Scientific Corporation
- 510(k) number
- K200257
- Product code
- MQR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-04-17
- Date received
- 2020-02-03
- Regulation
- 878.3610
- Classification name
- Stent, Colonic, Metallic, Expandable
- Medical specialty
- General & Plastic Surgery
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Catherine Sanford
- Address
- 100 Boston Scientific Way Marlboro MA US 01752 01752
FDA Registration Numbers#
- 3001845648
- 3040096051
- 3010173425
- 3005580113
- 3011458193
- 3003902943
- 3009526575
- 3008146331
- 3010273872
- 3005099803
- 1000121056
- 9681260
- 3002807314
Source Documents#
Other 510(k) Records For Product Code MQR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K201159 | WallFlex Colonic Stent System with Anchor Lock Delivery System | Boston Scientific Corporation | 2020-08-17 |
| K190141 | HANAROSTENT LowAx Colon/Rectum (NNN) | M.I.Tech Co., Ltd. | 2019-03-07 |
| K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) | M.I.Tech Co., Ltd. | 2019-01-10 |
| K180180 | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) | M.I.Tech Co., Ltd. | 2018-11-02 |
| K113510 | EVOLUTION COLONIC STENT SYSTEM | Cook Ireland, Ltd. | 2012-05-17 |
| K061877 | WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM | Boston Scientific Corp | 2006-09-15 |
| K060323 | ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 | Boston Scientific Corporation | 2006-05-12 |
| K042065 | WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM | Boston Scientific Corp | 2004-09-30 |
| K030769 | ULTRAFLEX PRECISION COLONIC STENT | Boston Scientific Corp | 2003-07-14 |
| K000281 | WALLSTENT ENTERNAL PROSTHESIS | Boston Scientific Corp | 2000-05-12 |
| K990034 | WILSON-COOK COLONIC Z-STENT | Med Institute, Inc. | 2000-04-17 |
| K990504 | MEMOTHERM COLORECTAL STENT | C.R. Bard, Inc. | 2000-03-16 |
| K991056 | WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM | Boston Scientific Corp | 1999-06-22 |
| K954290 | WALLSTENT ENTERAL ENDOPROTHESIS | Boston Scientific Scimed, Inc. | 1996-07-10 |
Legacy Summary#
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FDA Review#
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