WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM— 510(k) K042065

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K042065 for WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM, Substantially Equivalent on 2004-09-30. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code MQR
Advisory panel: General, Plastic Surgery
Date received: 2004-08-02
Decision date: 2004-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick,, MA, US

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Adverse events under product code MQR

product code MQR

Death: 11
Injury: 149
Total: 160

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.