CytoCore
K-Number: K200278 · 2020-03-31
ApplicantPraxis Medical, LLC
Decision Date2020-03-31
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
CytoCore is a medical device manufactured by Praxis Medical, LLC. It received FDA 510(k) clearance on 2020-03-31 under approval number K200278. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CytoCore?
CytoCore is a medical device that received FDA 510(k) clearance on 2020-03-31. It is manufactured by Praxis Medical, LLC. The 510(k) number is K200278.
When was CytoCore approved by the FDA?
CytoCore received FDA 510(k) clearance on 2020-03-31, under approval number K200278.
What company makes CytoCore?
CytoCore is manufactured by Praxis Medical, LLC.
What is the FDA product code for CytoCore?
The FDA product code for CytoCore is KNW.
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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.