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FDA 510(k)

Disposable Insulin Pen Needle

K-Number: K222739 · 2023-04-06

ApplicantHantech Medical Device Co., Ltd.
Decision Date2023-04-06
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Insulin Pen Needle is a medical device manufactured by Hantech Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2023-04-06 under approval number K222739. 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 Disposable Insulin Pen Needle?

Disposable Insulin Pen Needle is a medical device that received FDA 510(k) clearance on 2023-04-06. It is manufactured by Hantech Medical Device Co., Ltd.. The 510(k) number is K222739.

When was Disposable Insulin Pen Needle approved by the FDA?

Disposable Insulin Pen Needle received FDA 510(k) clearance on 2023-04-06, under approval number K222739.

What company makes Disposable Insulin Pen Needle?

Disposable Insulin Pen Needle is manufactured by Hantech Medical Device Co., Ltd..

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

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

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Other Devices by Hantech Medical Device Co., Ltd.

K221038Disposable Medical Masks K220603Disposable Medical Safety Hypodermic Needle K231363Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) K222672Disposable 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

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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