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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2016-07-26 under 510(k) 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. The listed applicant is Cook Incorporated. The 510(k) number is K160887.

When did Cook Intraosseous Infusion Needles receive FDA 510(k) clearance?

Cook Intraosseous Infusion Needles received FDA 510(k) clearance on 2016-07-26, under 510(k) number K160887.

Who is the listed applicant for Cook Intraosseous Infusion Needles?

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

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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Related Devices (Code: FMI)

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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Official Source

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

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