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FDA 510(k)

Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle

K-Number: K222124 · 2022-11-04

ApplicantAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Decision Date2022-11-04
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle is a medical device manufactured by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2022-11-04 under approval number K222124. 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 Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle?

Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle is a medical device that received FDA 510(k) clearance on 2022-11-04. It is manufactured by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. The 510(k) number is K222124.

When was Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle approved by the FDA?

Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle received FDA 510(k) clearance on 2022-11-04, under approval number K222124.

What company makes Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle?

Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle is manufactured by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd..

What is the FDA product code for Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle?

The FDA product code for Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle is FMI.

Related Clinical Trials

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Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

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 K222141Safety Blood Collection Needle (Without Needle Holder) K220900Safety Blood Collection Needles with/without Needle Holder K220083LDV((Low Dead Volume )Syringe

View all 12 devices →

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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