AMICUS Separator System— 510(k) K200530

Substantially Equivalent

Fresenius Kabi AG

FDA 510(k) clearance K200530 for AMICUS Separator System, Substantially Equivalent on 2020-09-11. Applicant: Fresenius Kabi AG.

Clearance details

Applicant: Fresenius Kabi AG
Product code: Code GKT
Advisory panel: Hematology
Date received: 2020-03-02
Decision date: 2020-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Zurich, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GKT

product code GKT

Death: 167
Injury: 301
Malfunction: 2,086
Total: 2,554

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.