easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use— 510(k) K172960

Substantially Equivalent

Ezisurg Medical Co., Ltd.

FDA 510(k) clearance K172960 for easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use, Substantially Equivalent on 2017-12-21. Applicant: Ezisurg Medical Co., Ltd..

Clearance details

Applicant: Ezisurg Medical Co., Ltd.
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 2017-09-26
Decision date: 2017-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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.