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FDA 510(k)

Disposable Syringe with Needle

K-Number: K211482 · 2022-01-24

ApplicantShandong Qinkai Medical Industry Co., Ltd.
Decision Date2022-01-24
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Syringe with Needle is a medical device manufactured by Shandong Qinkai Medical Industry Co., Ltd.. It received FDA 510(k) clearance on 2022-01-24 under approval number K211482. 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 Needle?

Disposable Syringe with Needle is a medical device that received FDA 510(k) clearance on 2022-01-24. It is manufactured by Shandong Qinkai Medical Industry Co., Ltd.. The 510(k) number is K211482.

When was Disposable Syringe with Needle approved by the FDA?

Disposable Syringe with Needle received FDA 510(k) clearance on 2022-01-24, under approval number K211482.

What company makes Disposable Syringe with Needle?

Disposable Syringe with Needle is manufactured by Shandong Qinkai Medical Industry Co., Ltd..

What is the FDA product code for Disposable Syringe with Needle?

The FDA product code for Disposable Syringe with Needle is FMF.

Related Clinical Trials

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 NCT07548892 Comparison of Needle-Free Injection and Conventional Syringe for Tooth Extractions in Children NOT_YET_RECRUITING NCT07498621 Assessment of Maxillary Local Anesthesia Infiltration Using Needle-free Jet vs Conventional Syringe in Tooth Extraction COMPLETED

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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