FDA 510(k)

Sungshim Insulin Pen Needle

K-Number: K152334 · 2016-03-17

Decision Date2016-03-17

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Sungshim Insulin Pen Needle is a medical device manufactured by Sung Shim Medicare Co., Ltd.. It received FDA 510(k) clearance on 2016-03-17 under approval number K152334. 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 Sungshim Insulin Pen Needle?

Sungshim Insulin Pen Needle is a medical device that received FDA 510(k) clearance on 2016-03-17. It is manufactured by Sung Shim Medicare Co., Ltd.. The 510(k) number is K152334.

When was Sungshim Insulin Pen Needle approved by the FDA?

Sungshim Insulin Pen Needle received FDA 510(k) clearance on 2016-03-17, under approval number K152334.

What company makes Sungshim Insulin Pen Needle?

Sungshim Insulin Pen Needle is manufactured by Sung Shim Medicare Co., Ltd..

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

The FDA product code for Sungshim Insulin Pen Needle is FMI.

Related Clinical Trials

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Other Devices by Sung Shim Medicare Co., Ltd.

K152803SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE

Related Devices (Code: FMI)

K162516BD Pen NeedleBecton, Dickinson and Company K160532Greiner HoldexGreiner Bio-One Na, Inc. K160199Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc. K151090CPL Insulin Pen NeedleCpl Co., Ltd. K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc. K153706Insulin Pen NeedleSteriLance Medical (Suzhou), Inc.

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.