FDA 510(k)

CareSens Pen Needle, Softip Pen Needle

K-Number: K160575 · 2016-09-07

Decision Date2016-09-07

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

CareSens Pen Needle, Softip Pen Needle is a medical device manufactured by Yidobio, Inc.. It received FDA 510(k) clearance on 2016-09-07 under approval number K160575. 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 CareSens Pen Needle, Softip Pen Needle?

CareSens Pen Needle, Softip Pen Needle is a medical device that received FDA 510(k) clearance on 2016-09-07. It is manufactured by Yidobio, Inc.. The 510(k) number is K160575.

When was CareSens Pen Needle, Softip Pen Needle approved by the FDA?

CareSens Pen Needle, Softip Pen Needle received FDA 510(k) clearance on 2016-09-07, under approval number K160575.

What company makes CareSens Pen Needle, Softip Pen Needle?

CareSens Pen Needle, Softip Pen Needle is manufactured by Yidobio, Inc..

What is the FDA product code for CareSens Pen Needle, Softip Pen Needle?

The FDA product code for CareSens Pen Needle, Softip 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.