WallFlex Colonic Stent System with Anchor Lock Delivery System— 510(k) K201159
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K201159 for WallFlex Colonic Stent System with Anchor Lock Delivery System, Substantially Equivalent on 2020-08-17. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code MQR
- Device class
- Class 2
- Regulation
- 21 CFR 878.3610
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlboro, MA, US
Recent devices under product code MQR
view all- K234046 — WallFlex Colonic Stent System with Anchor Lock Delivery System +3 more
- K200257 — WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
- K190141 — HANAROSTENT LowAx Colon/Rectum (NNN)
- K183616 — HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
- K180180 — HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
More clearances from Boston Scientific Corporation
view allAdverse events under product code MQR
product code MQR- Death
- 11
- Injury
- 149
- Total
- 160
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.