EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM— 510(k) K141206

Name: FDA 510(k) clearance K141206
Creator: U.S. Food and Drug Administration
Published: 2015-01-16

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K141206 for EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM, Substantially Equivalent on 2015-01-16. Applicant: Edwards Lifesciences, LLC. Device class: 2.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code GAW
Device class: Class 2
Regulation: 21 CFR 878.5010
Advisory panel: General, Plastic Surgery
Date received: 2014-05-09
Decision date: 2015-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Draper, UT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GAW

product code GAW

Death: 66
Injury: 1,616
Malfunction: 10,428
Total: 12,110

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.