WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM— 510(k) K991056

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K991056 for WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM, Substantially Equivalent on 1999-06-22. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code MQR
Advisory panel: General, Plastic Surgery
Date received: 1999-03-30
Decision date: 1999-06-22
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.