FDA 510(k)

BD Nano 2nd Gen Pen Needle

K-Number: K213156 · 2021-12-08

Decision Date2021-12-08

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BD Nano 2nd Gen Pen Needle is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2021-12-08 under approval number K213156. 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 Nano 2nd Gen Pen Needle?

BD Nano 2nd Gen Pen Needle is a medical device that received FDA 510(k) clearance on 2021-12-08. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K213156.

When was BD Nano 2nd Gen Pen Needle approved by the FDA?

BD Nano 2nd Gen Pen Needle received FDA 510(k) clearance on 2021-12-08, under approval number K213156.

What company makes BD Nano 2nd Gen Pen Needle?

BD Nano 2nd Gen Pen Needle is manufactured by Becton, Dickinson and Company.

What is the FDA product code for BD Nano 2nd Gen Pen Needle?

The FDA product code for BD Nano 2nd Gen Pen Needle is FMI.

Other Devices by Becton, Dickinson and Company

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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.