510(k) K201639— Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads

Substantially Equivalent

Beijing Biosis Healing Biolog Ical Technology Co., Ltd.

Clearance details

Applicant: Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 2020-06-16
Decision date: 2021-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, 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.