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FDA 510(k)

AMICUS Separator System

K-Number: K200530 · 2020-09-11

ApplicantFresenius Kabi AG
Decision Date2020-09-11
Product CodeGKT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AMICUS Separator System is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Kabi AG. It received FDA 510(k) clearance on 2020-09-11 under 510(k) number K200530. The device is classified under product code GKT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMICUS Separator System?

AMICUS Separator System is a medical device that received FDA 510(k) clearance on 2020-09-11. The listed applicant is Fresenius Kabi AG. The 510(k) number is K200530.

When did AMICUS Separator System receive FDA 510(k) clearance?

AMICUS Separator System received FDA 510(k) clearance on 2020-09-11, under 510(k) number K200530.

Who is the listed applicant for AMICUS Separator System?

The FDA 510(k) record lists Fresenius Kabi AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMICUS Separator System?

The FDA product code for AMICUS Separator System is GKT.

Other records listing Fresenius Kabi AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: GKT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162462AMICUS Separator System, AMICUS Separator System; RefurbishedFresenius Kabi USA,Llc

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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