Cook Intraosseous Infusion Needles
K-Number: K160887 · 2016-07-26
ApplicantCook Incorporated
Decision Date2016-07-26
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Cook Intraosseous Infusion Needles is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2016-07-26 under approval number K160887. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cook Intraosseous Infusion Needles?
Cook Intraosseous Infusion Needles is a medical device that received FDA 510(k) clearance on 2016-07-26. It is manufactured by Cook Incorporated. The 510(k) number is K160887.
When was Cook Intraosseous Infusion Needles approved by the FDA?
Cook Intraosseous Infusion Needles received FDA 510(k) clearance on 2016-07-26, under approval number K160887.
What company makes Cook Intraosseous Infusion Needles?
Cook Intraosseous Infusion Needles is manufactured by Cook Incorporated.
What is the FDA product code for Cook Intraosseous Infusion Needles?
The FDA product code for Cook Intraosseous Infusion Needles is FMI.
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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.