DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE)— 510(k) K864146

Name: FDA 510(k) clearance K864146
Creator: U.S. Food and Drug Administration
Published: 1986-11-05

Substantially Equivalent

Cardio Thoracic Systems

FDA 510(k) clearance K864146 for DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE), Substantially Equivalent on 1986-11-05. Applicant: Cardio Thoracic Systems. Device class: 2.

Clearance details

Applicant: Cardio Thoracic Systems
Product code: Code GDW
Device class: Class 2
Regulation: 21 CFR 878.4750
Advisory panel: General, Plastic Surgery
Date received: 1986-10-22
Decision date: 1986-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cupertino, CA, US

Download summary PDF View on FDA.gov ↗

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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.