WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
FDA 510(k) K200257 · Boston Scientific Corporation
510(k) numberK200257
Submission
- Device name
- WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
- Applicant
- Boston Scientific Corporation
Marlboro, MA, US - Received
- February 3, 2020
- Decision date
- April 17, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQR – Stent, Colonic, Metallic, Expandable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3610
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code MQR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K234046 | WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent…MQR · Special | Boston Scientific Corporation | 03/08/2024SE |
| K201159 | WallFlex Colonic Stent System with Anchor Lock Delivery SystemMQR · Traditional | Boston Scientific Corporation | 08/17/2020SE |
| K190141 | HANAROSTENT LowAx Colon/Rectum (NNN)MQR · Special | M.I.Tech Co., Ltd. | 03/07/2019SE |
| K183616 | HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)MQR · Traditional | M.I.Tech Co., Ltd. | 01/10/2019SE |
| K180180 | HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)MQR · Traditional | M.I.Tech Co., Ltd. | 11/02/2018SE |
| K113510 | Evolution Colonic Stent SystemMQR · Traditional | Cook Ireland, Ltd. | 05/17/2012SE |
| K061877 | Wallflex Enteral Colonic Stent with Anchor Lock Delivery SystemMQR · Traditional | Boston Scientific Corp | 09/15/2006SE |
| K060323 | Ultraflex Precision Colonic Stent, Models M00557330, MO00557360, M00557380MQR · Traditional | Boston Scientific Corporation | 05/12/2006SE |
| K042065 | Wallflex Enternal Colonic Stent and Anchor Lock Delivery SystemMQR · Traditional | Boston Scientific Corp | 09/30/2004SE |
| K030769 | Ultraflex Precision Colonic StentMQR · Traditional | Boston Scientific Corp | 07/14/2003SE |
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Questions and answers
When was WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System cleared by the FDA?
WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System (K200257) received a 510(k) decision of Substantially Equivalent on April 17, 2020, 74 days after the submission was received.
What is the product code of K200257?
The FDA product code is MQR – Stent, Colonic, Metallic, Expandable, a Class II (moderate risk) device regulated under 21 CFR 878.3610.