WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030— 510(k) K062750

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K062750 for WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030, Substantially Equivalent on 2006-12-04. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: 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

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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.