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FDA 510(k)

Insulin Syringe

K-Number: K230061 · 2023-11-30

ApplicantAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Decision Date2023-11-30
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Insulin Syringe is a medical device manufactured by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2023-11-30 under approval number K230061. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Insulin Syringe?

Insulin Syringe is a medical device that received FDA 510(k) clearance on 2023-11-30. It is manufactured by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. The 510(k) number is K230061.

When was Insulin Syringe approved by the FDA?

Insulin Syringe received FDA 510(k) clearance on 2023-11-30, under approval number K230061.

What company makes Insulin Syringe?

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

What is the FDA product code for Insulin Syringe?

The FDA product code for Insulin Syringe is FMF.

Related Clinical Trials

NCT02812927 Evaluation of Glycemic Variability (GLAIVE) COMPLETED

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: FMF)

K162180Disposable Insulin SyringeBerpu Medical Technology Co., Ltd. K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin SyringeBecton, Dickinson and Company K162602NovoPen EchoNovo Nordisk, Inc. K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. K152879Sure-Fine Insulin SyringesShina Med Corporation K160629InPenCompanion Medical, 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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