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FDA 510(k)

Disposable Insulin Syringe

K-Number: K222672 · 2023-03-06

ApplicantHantech Medical Device Co., Ltd.
Decision Date2023-03-06
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Insulin Syringe is a medical device manufactured by Hantech Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2023-03-06 under approval number K222672. 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 Disposable Insulin Syringe?

Disposable Insulin Syringe is a medical device that received FDA 510(k) clearance on 2023-03-06. It is manufactured by Hantech Medical Device Co., Ltd.. The 510(k) number is K222672.

When was Disposable Insulin Syringe approved by the FDA?

Disposable Insulin Syringe received FDA 510(k) clearance on 2023-03-06, under approval number K222672.

What company makes Disposable Insulin Syringe?

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

What is the FDA product code for Disposable Insulin Syringe?

The FDA product code for Disposable Insulin Syringe is FMF.

Related Clinical Trials

NCT07228117 GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes RECRUITING NCT02812927 Evaluation of Glycemic Variability (GLAIVE) COMPLETED

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) K222739Disposable Insulin Pen Needle

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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