FDA 510(k)

Hypodermic Needle-Pro EDGE Safety Device

K-Number: K211634 · 2021-08-26

Decision Date2021-08-26

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Hypodermic Needle-Pro EDGE Safety Device is a medical device manufactured by Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2021-08-26 under approval number K211634. 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 Hypodermic Needle-Pro EDGE Safety Device?

Hypodermic Needle-Pro EDGE Safety Device is a medical device that received FDA 510(k) clearance on 2021-08-26. It is manufactured by Smiths Medical Asd, Inc.. The 510(k) number is K211634.

When was Hypodermic Needle-Pro EDGE Safety Device approved by the FDA?

Hypodermic Needle-Pro EDGE Safety Device received FDA 510(k) clearance on 2021-08-26, under approval number K211634.

What company makes Hypodermic Needle-Pro EDGE Safety Device?

Hypodermic Needle-Pro EDGE Safety Device is manufactured by Smiths Medical Asd, Inc..

What is the FDA product code for Hypodermic Needle-Pro EDGE Safety Device?

The FDA product code for Hypodermic Needle-Pro EDGE Safety Device 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.