K162947

Substantially Equivalent

Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler

Applicant: Chongqing Qmi Surgical Co., Ltd.
Product code: GDW
Advisory panel: General, Plastic Surgery
Date received: 2016-10-21
Decision date: 2017-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chongqing, CN

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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.