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FDA 510(k)

Insulin Pen Needle

K-Number: K230043 · 2023-09-20

ApplicantAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Decision Date2023-09-20
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Insulin Pen Needle is a medical device manufactured by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2023-09-20 under approval number K230043. 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 Insulin Pen Needle?

Insulin Pen Needle is a medical device that received FDA 510(k) clearance on 2023-09-20. It is manufactured by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. The 510(k) number is K230043.

When was Insulin Pen Needle approved by the FDA?

Insulin Pen Needle received FDA 510(k) clearance on 2023-09-20, under approval number K230043.

What company makes Insulin Pen Needle?

Insulin Pen Needle is manufactured by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd..

What is the FDA product code for Insulin Pen Needle?

The FDA product code for Insulin Pen Needle is FMI.

Related Clinical Trials

NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine RECRUITING

Other Devices by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

K190183Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe K211555Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe K202188Safety Blood Collection Sets for Single Use K222124Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle K222141Safety Blood Collection Needle (Without Needle Holder) K220900Safety Blood Collection Needles with/without Needle Holder

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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