Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (3 models)— 510(k) K242679

Name: FDA 510(k) clearance K242679
Creator: U.S. Food and Drug Administration
Published: 2024-10-04

Substantially Equivalent

Fengh Medical Co., Ltd.

FDA 510(k) clearance K242679 for Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (3 models), Substantially Equivalent on 2024-10-04. Applicant: Fengh Medical Co., Ltd.. Device class: 2.

Clearance details

Device name as filed: Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series)
Applicant: Fengh Medical Co., Ltd.
Product code: Code GDW
Device class: Class 2
Regulation: 21 CFR 878.4750
Advisory panel: General, Plastic Surgery
Date received: 2024-09-06
Decision date: 2024-10-04
Decision: Substantially Equivalent
Clearance type: Special
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

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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.