FDA 510(k)

UltiCare Disposable Pen Needles

K-Number: K213407 · 2021-12-16

Decision Date2021-12-16

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

UltiCare Disposable Pen Needles is a medical device manufactured by Ultimed Incorporated. It received FDA 510(k) clearance on 2021-12-16 under approval number K213407. 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 UltiCare Disposable Pen Needles?

UltiCare Disposable Pen Needles is a medical device that received FDA 510(k) clearance on 2021-12-16. It is manufactured by Ultimed Incorporated. The 510(k) number is K213407.

When was UltiCare Disposable Pen Needles approved by the FDA?

UltiCare Disposable Pen Needles received FDA 510(k) clearance on 2021-12-16, under approval number K213407.

What company makes UltiCare Disposable Pen Needles?

UltiCare Disposable Pen Needles is manufactured by Ultimed Incorporated.

What is the FDA product code for UltiCare Disposable Pen Needles?

The FDA product code for UltiCare Disposable Pen Needles is 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.