FDA 510(k)

Clickfine Pen Needle, Penfine Classic Pen Needle

K-Number: K171984 · 2017-10-11

Decision Date2017-10-11

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Clickfine Pen Needle, Penfine Classic Pen Needle is a medical device manufactured by Ypsomed AG. It received FDA 510(k) clearance on 2017-10-11 under approval number K171984. 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 Clickfine Pen Needle, Penfine Classic Pen Needle?

Clickfine Pen Needle, Penfine Classic Pen Needle is a medical device that received FDA 510(k) clearance on 2017-10-11. It is manufactured by Ypsomed AG. The 510(k) number is K171984.

When was Clickfine Pen Needle, Penfine Classic Pen Needle approved by the FDA?

Clickfine Pen Needle, Penfine Classic Pen Needle received FDA 510(k) clearance on 2017-10-11, under approval number K171984.

What company makes Clickfine Pen Needle, Penfine Classic Pen Needle?

Clickfine Pen Needle, Penfine Classic Pen Needle is manufactured by Ypsomed AG.

What is the FDA product code for Clickfine Pen Needle, Penfine Classic Pen Needle?

The FDA product code for Clickfine Pen Needle, Penfine Classic Pen Needle is FMI.

Other Devices by Ypsomed AG

K150921Orbit Infusion Set K163400Orbit Inserter K243901SmartPilot YpsoMate NS-A2.25

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.