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FDA 510(k)

Disposable Insulin Pen Needle

K-Number: K181069 · 2018-08-28

ApplicantZhejiang Kindly Medical Devices Co., Ltd.
Decision Date2018-08-28
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Insulin Pen Needle is a medical device manufactured by Zhejiang Kindly Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2018-08-28 under approval number K181069. 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 2018-08-28. It is manufactured by Zhejiang Kindly Medical Devices Co., Ltd.. The 510(k) number is K181069.

When was Disposable Insulin Pen Needle approved by the FDA?

Disposable Insulin Pen Needle received FDA 510(k) clearance on 2018-08-28, under approval number K181069.

What company makes Disposable Insulin Pen Needle?

Disposable Insulin Pen Needle is manufactured by Zhejiang Kindly Medical Devices Co., Ltd..

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

The FDA product code for Disposable 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 NCT07228117 GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes RECRUITING

Other Devices by Zhejiang Kindly Medical Devices Co., Ltd.

K172763Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder K171518Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles K223334Sterile Hypodermic Needles for Single Use K213183Safety Insulin Pen 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

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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