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FDA 510(k)

Sterile Single-use Syringe with Needle

K-Number: K163161 · 2017-03-20

ApplicantJiangxi Hongda Medical Equipment Group , Ltd.
Decision Date2017-03-20
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Single-use Syringe with Needle 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 K163161. 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 Sterile Single-use Syringe with Needle?

Sterile Single-use Syringe with Needle 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 K163161.

When was Sterile Single-use Syringe with Needle approved by the FDA?

Sterile Single-use Syringe with Needle received FDA 510(k) clearance on 2017-03-20, under approval number K163161.

What company makes Sterile Single-use Syringe with Needle?

Sterile Single-use Syringe with Needle is manufactured by Jiangxi Hongda Medical Equipment Group , Ltd..

What is the FDA product code for Sterile Single-use Syringe with Needle?

The FDA product code for Sterile Single-use Syringe with Needle is FMF.

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 Jiangxi Hongda Medical Equipment Group , Ltd.

K163160Sterile Single-use Infusion Set K163162Sterile Hypodermic Safety Syringes for Single Use K211753Sterile Syringe With Safety Needle K210578Medical Nitrile Examination Gloves (Power free, Blue) K210821Medical PVC Examination Gloves

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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