FDA 510(k)

BD AutoShield Duo Pen Needle

K-Number: K223286 · 2022-12-28

Decision Date2022-12-28

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BD AutoShield Duo Pen Needle is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2022-12-28 under approval number K223286. 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 AutoShield Duo Pen Needle?

BD AutoShield Duo Pen Needle is a medical device that received FDA 510(k) clearance on 2022-12-28. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K223286.

When was BD AutoShield Duo Pen Needle approved by the FDA?

BD AutoShield Duo Pen Needle received FDA 510(k) clearance on 2022-12-28, under approval number K223286.

What company makes BD AutoShield Duo Pen Needle?

BD AutoShield Duo Pen Needle is manufactured by Becton, Dickinson and Company.

What is the FDA product code for BD AutoShield Duo Pen Needle?

The FDA product code for BD AutoShield Duo Pen Needle is FMI.

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Related Devices (Code: 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.