510(k) K211811— Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers

Substantially Equivalent

Wuxi Beien Surgery Device Co., Ltd.

Clearance details

Applicant: Wuxi Beien Surgery Device Co., Ltd.
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 2021-06-11
Decision date: 2022-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuxi, CN

Adverse events under product code GDW

product code GDW

Death: 450
Injury: 12,684
Malfunction: 68,730
Other: 6
Total: 81,870

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.