FDA 510(k)

Pen Needle

K-Number: K252886 · 2026-01-06

Decision Date2026-01-06

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Pen Needle is a medical device manufactured by Hh Global Technology, Inc.. It received FDA 510(k) clearance on 2026-01-06 under approval number K252886. 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 Pen Needle?

Pen Needle is a medical device that received FDA 510(k) clearance on 2026-01-06. It is manufactured by Hh Global Technology, Inc.. The 510(k) number is K252886.

When was Pen Needle approved by the FDA?

Pen Needle received FDA 510(k) clearance on 2026-01-06, under approval number K252886.

What company makes Pen Needle?

Pen Needle is manufactured by Hh Global Technology, Inc..

What is the FDA product code for Pen Needle?

The FDA product code for Pen Needle is FMI.

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.