510(k) K161905— Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge

Substantially Equivalent

Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd

Clearance details

Applicant: Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 2016-07-11
Decision date: 2016-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou, 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.