FDA 510(k)

Sterile Hypodermic Safety Syringes for Single Use

K-Number: K163162 · 2017-03-20

ApplicantJiangxi Hongda Medical Equipment Group , Ltd.

Decision Date2017-03-20

Product CodeMEG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Sterile Hypodermic Safety Syringes for Single Use is a medical device manufactured by Jiangxi Hongda Medical Equipment Group , Ltd.. It received FDA 510(k) clearance on 2017-03-20 under approval number K163162. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterile Hypodermic Safety Syringes for Single Use?

Sterile Hypodermic Safety Syringes for Single Use is a medical device that received FDA 510(k) clearance on 2017-03-20. It is manufactured by Jiangxi Hongda Medical Equipment Group , Ltd.. The 510(k) number is K163162.

When was Sterile Hypodermic Safety Syringes for Single Use approved by the FDA?

Sterile Hypodermic Safety Syringes for Single Use received FDA 510(k) clearance on 2017-03-20, under approval number K163162.

What company makes Sterile Hypodermic Safety Syringes for Single Use?

Sterile Hypodermic Safety Syringes for Single Use is manufactured by Jiangxi Hongda Medical Equipment Group , Ltd..

What is the FDA product code for Sterile Hypodermic Safety Syringes for Single Use?

The FDA product code for Sterile Hypodermic Safety Syringes for Single Use is MEG.

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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) PMID: 41090443 Confirmatory evidence supporting single pivotal trial new drug approvals by the Food and Drug Administration, 2015 through 2023. Clinical trials (London, England) (2026)

Other Devices by Jiangxi Hongda Medical Equipment Group , Ltd.

K163160Sterile Single-use Infusion Set K163161Sterile Single-use Syringe with Needle K211753Sterile Syringe With Safety Needle K210578Medical Nitrile Examination Gloves (Power free, Blue) K210821Medical PVC Examination Gloves

Related Devices (Code: MEG)

K1620300.5ml Sol-Care Retractable Safety Syringe with Fixed NeedleSol-Millennium Medical, Inc. K152606Jeesung Safety Syringe and Single Use NeedlesJeesung Medical Co., Ltd. K152808U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd. K170651Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable NeedleYangzhou Medline Industry, Co., Ltd. K163511NovaGuard SA Pro Safety SystemWest Pharmaceutical Services, Inc. K180417Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single UseBerpu Medical Technology Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.