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FDA 510(k)

Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use

K-Number: K212857 · 2023-05-09

ApplicantJiangsu Zhiyu Medical Instrument Co, Ltd.
Decision Date2023-05-09
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use is a medical device manufactured by Jiangsu Zhiyu Medical Instrument Co, Ltd.. It received FDA 510(k) clearance on 2023-05-09 under approval number K212857. 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 Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use?

Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use is a medical device that received FDA 510(k) clearance on 2023-05-09. It is manufactured by Jiangsu Zhiyu Medical Instrument Co, Ltd.. The 510(k) number is K212857.

When was Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use approved by the FDA?

Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use received FDA 510(k) clearance on 2023-05-09, under approval number K212857.

What company makes Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use?

Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use is manufactured by Jiangsu Zhiyu Medical Instrument Co, Ltd..

What is the FDA product code for Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use?

The FDA product code for Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use is FMF.

Related Clinical Trials

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED NCT07240818 Comparison of FNB to EUS-CNB for Pancreatic Lesions NOT_YET_RECRUITING NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT07540806 Ultrasound-Guided Percutaneous Needle Tenotomy (PNT) vs Percutaneous Ultrasonic Needle Tenotomy (PUT) for Gluteal Tendinosis NOT_YET_RECRUITING NCT07581249 This Study Evaluate the Patient Response to Jet Injection, Pain and Satisfaction Compared to Conventional Method of Local Anasthesia Especially in Maxillary Teeth COMPLETED

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)

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 →

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