FDA 510(k)

JSM Insulin Pen Needle

K-Number: K152166 · 2016-07-11

Decision Date2016-07-11

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

JSM Insulin Pen Needle is a medical device manufactured by Jeesung Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-07-11 under approval number K152166. 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 JSM Insulin Pen Needle?

JSM Insulin Pen Needle is a medical device that received FDA 510(k) clearance on 2016-07-11. It is manufactured by Jeesung Medical Co., Ltd.. The 510(k) number is K152166.

When was JSM Insulin Pen Needle approved by the FDA?

JSM Insulin Pen Needle received FDA 510(k) clearance on 2016-07-11, under approval number K152166.

What company makes JSM Insulin Pen Needle?

JSM Insulin Pen Needle is manufactured by Jeesung Medical Co., Ltd..

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

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

Related Clinical Trials

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Other Devices by Jeesung Medical Co., Ltd.

K152606Jeesung Safety Syringe and Single Use Needles K212518Jeesung Safety Syringe and Single Use Needles

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.