AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED— 510(k) K141019

Substantially Equivalent

Fenwal, Inc.

FDA 510(k) clearance K141019 for AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED, Substantially Equivalent on 2014-06-10. Applicant: Fenwal, Inc..

Clearance details

Applicant: Fenwal, Inc.
Product code: Code LKN
Advisory panel: Unknown
Date received: 2014-04-21
Decision date: 2014-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Zurich, IL, US

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Adverse events under product code LKN

product code LKN

Death: 50
Injury: 314
Total: 364

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.