FDA 510(k)

CPL Insulin Pen Needle

K-Number: K151090 · 2016-09-21

Decision Date2016-09-21

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

CPL Insulin Pen Needle is a medical device manufactured by Cpl Co., Ltd.. It received FDA 510(k) clearance on 2016-09-21 under approval number K151090. 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 CPL Insulin Pen Needle?

CPL Insulin Pen Needle is a medical device that received FDA 510(k) clearance on 2016-09-21. It is manufactured by Cpl Co., Ltd.. The 510(k) number is K151090.

When was CPL Insulin Pen Needle approved by the FDA?

CPL Insulin Pen Needle received FDA 510(k) clearance on 2016-09-21, under approval number K151090.

What company makes CPL Insulin Pen Needle?

CPL Insulin Pen Needle is manufactured by Cpl Co., Ltd..

What is the FDA product code for CPL Insulin Pen Needle?

The FDA product code for CPL Insulin Pen Needle 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.