AMICUS Separator System, AMICUS Separator System; Refurbished— 510(k) K162462

Substantially Equivalent

Fresenius Kabi USA,Llc

FDA 510(k) clearance K162462 for AMICUS Separator System, AMICUS Separator System; Refurbished, Substantially Equivalent on 2016-11-23. Applicant: Fresenius Kabi USA,Llc.

Clearance details

Applicant: Fresenius Kabi USA,Llc
Product code: Code GKT
Advisory panel: Hematology
Date received: 2016-09-02
Decision date: 2016-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Zurich, IL, US

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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.