DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32— 510(k) K100386

Substantially Equivalent

Changzhou Waston Medical Appliance Co., Ltd.

FDA 510(k) clearance K100386 for DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32, Substantially Equivalent on 2010-03-01. Applicant: Changzhou Waston Medical Appliance Co., Ltd..

Clearance details

Applicant: Changzhou Waston Medical Appliance Co., Ltd.
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 2010-02-16
Decision date: 2010-03-01
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.