FDA 510(k)

BD Eclipse Hypodermic Needle

K-Number: K161170 · 2016-05-27

Decision Date2016-05-27

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BD Eclipse Hypodermic Needle is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2016-05-27 under 510(k) number K161170. 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 BD Eclipse Hypodermic Needle?

BD Eclipse Hypodermic Needle is a medical device that received FDA 510(k) clearance on 2016-05-27. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K161170.

When did BD Eclipse Hypodermic Needle receive FDA 510(k) clearance?

BD Eclipse Hypodermic Needle received FDA 510(k) clearance on 2016-05-27, under 510(k) number K161170.

Who is the listed applicant for BD Eclipse Hypodermic Needle?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Eclipse Hypodermic Needle?

The FDA product code for BD Eclipse Hypodermic Needle is FMI.

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Related Devices (Code: FMI)

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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.