Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers— 510(k) K211458

Name: FDA 510(k) clearance K211458
Creator: U.S. Food and Drug Administration
Published: 2021-12-30

Substantially Equivalent

Ningbo Verykind Medical Device Co., Ltd.

FDA 510(k) clearance K211458 for Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers, Substantially Equivalent on 2021-12-30. Applicant: Ningbo Verykind Medical Device Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ningbo Verykind Medical Device Co., Ltd.
Product code: Code GDW
Device class: Class 2
Regulation: 21 CFR 878.4750
Advisory panel: General, Plastic Surgery
Date received: 2021-05-11
Decision date: 2021-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ningbo, CN

Download summary PDF View on FDA.gov ↗

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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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K202709 — Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges2021-05-18

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.