AMICUS Separator System, AMICUS Separator System; Refurbished
K-Number: K162462 · 2016-11-23
ApplicantFresenius Kabi USA,Llc
Decision Date2016-11-23
Product CodeGKT
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
AMICUS Separator System, AMICUS Separator System; Refurbished is a medical device manufactured by Fresenius Kabi USA,Llc. It received FDA 510(k) clearance on 2016-11-23 under approval number K162462. 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; Refurbished?
AMICUS Separator System, AMICUS Separator System; Refurbished is a medical device that received FDA 510(k) clearance on 2016-11-23. It is manufactured by Fresenius Kabi USA,Llc. The 510(k) number is K162462.
When was AMICUS Separator System, AMICUS Separator System; Refurbished approved by the FDA?
AMICUS Separator System, AMICUS Separator System; Refurbished received FDA 510(k) clearance on 2016-11-23, under approval number K162462.
What company makes AMICUS Separator System, AMICUS Separator System; Refurbished?
AMICUS Separator System, AMICUS Separator System; Refurbished is manufactured by Fresenius Kabi USA,Llc.
What is the FDA product code for AMICUS Separator System, AMICUS Separator System; Refurbished?
The FDA product code for AMICUS Separator System, AMICUS Separator System; Refurbished is GKT.
Other Devices by Fresenius Kabi USA,Llc
Related Devices (Code: GKT)
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.