Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers— 510(k) K211811

Name: FDA 510(k) clearance K211811
Creator: U.S. Food and Drug Administration
Published: 2022-03-03

Substantially Equivalent

Wuxi Beien Surgery Device Co., Ltd.

FDA 510(k) clearance K211811 for Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers, Substantially Equivalent on 2022-03-03. Applicant: Wuxi Beien Surgery Device Co., Ltd.. Device class: 2.

Clearance details

Applicant: Wuxi Beien Surgery Device Co., Ltd.
Product code: Code GDW
Device class: Class 2
Regulation: 21 CFR 878.4750
Advisory panel: General, Plastic Surgery
Date received: 2021-06-11
Decision date: 2022-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuxi, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code GDW

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K260196 — ETHICON Circular Stapler (CDH21mm) +7 more2026-05-11
K253657 — Tri-staple 2.0 Reloads +3 more2026-04-10
K252739 — ETHICON 4000 45mm Compact Stapler (EC3DT45C) +6 more2025-12-17
K250835 — ETHICON 4000 60mm Compact Stapler (EC3D60C) +6 more2025-05-14
K243276 — ECHELON LINEAR Stapler 30mm Stapler (GTX30) +8 more2025-02-25

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.