WallFlex Colonic Stent System with Anchor Lock Delivery System +3 more— 510(k) K234046
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K234046 for WallFlex Colonic Stent System with Anchor Lock Delivery System +3 more, Substantially Equivalent on 2024-03-08. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Device name as filed
- 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
- 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
- Special
- Location
- Marborough, MA, US
Recent devices under product code MQR
view all- K201159 — WallFlex Colonic Stent System with Anchor Lock Delivery System
- 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.