FDA 510(k)

DropSafeTM SicuraTM

K-Number: K223353 · 2022-12-02

Decision Date2022-12-02

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

DropSafeTM SicuraTM is a medical device manufactured by Pikdare Spa. It received FDA 510(k) clearance on 2022-12-02 under approval number K223353. 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 DropSafeTM SicuraTM?

DropSafeTM SicuraTM is a medical device that received FDA 510(k) clearance on 2022-12-02. It is manufactured by Pikdare Spa. The 510(k) number is K223353.

When was DropSafeTM SicuraTM approved by the FDA?

DropSafeTM SicuraTM received FDA 510(k) clearance on 2022-12-02, under approval number K223353.

What company makes DropSafeTM SicuraTM?

DropSafeTM SicuraTM is manufactured by Pikdare Spa.

What is the FDA product code for DropSafeTM SicuraTM?

The FDA product code for DropSafeTM SicuraTM is FMI.

Other Devices by Pikdare Spa

K203792Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle

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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.