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FDA 510(k)

Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle

K-Number: K221308 · 2022-10-17

ApplicantJiangxi Maidikang Medical Devices Co., Ltd.
Decision Date2022-10-17
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle is a medical device manufactured by Jiangxi Maidikang Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-10-17 under approval number K221308. 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 Syringe with permanently attached needle, Safety Syringe with permanently attached needle?

Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle is a medical device that received FDA 510(k) clearance on 2022-10-17. It is manufactured by Jiangxi Maidikang Medical Devices Co., Ltd.. The 510(k) number is K221308.

When was Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle approved by the FDA?

Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle received FDA 510(k) clearance on 2022-10-17, under approval number K221308.

What company makes Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle?

Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle is manufactured by Jiangxi Maidikang Medical Devices Co., Ltd..

What is the FDA product code for Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle?

The FDA product code for Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle is FMF.

Related Clinical Trials

NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED NCT06000540 Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects NOT_YET_RECRUITING NCT06204614 Drug Screening Using IMD in Bladder Cancer ENROLLING_BY_INVITATION NCT07228117 GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes RECRUITING NCT05231278 Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy COMPLETED 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 →

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

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