K062750

Substantially Equivalent

WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030

Applicant: Boston Scientific Corp
Product code: MUM
Advisory panel: General, Plastic Surgery
Date received: 2006-09-14
Decision date: 2006-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, US

Adverse events under product code MUM

product code MUM

Death: 6
Injury: 137
Total: 143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.