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FDA 510(k)

Disposable Sterile Syringe, Disposable Sterile Syringe with Needle

K-Number: K210991 · 2021-08-26

ApplicantGuangdong Antmed Co., Ltd.
Decision Date2021-08-26
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Sterile Syringe, Disposable Sterile Syringe with Needle is a medical device manufactured by Guangdong Antmed Co., Ltd.. It received FDA 510(k) clearance on 2021-08-26 under approval number K210991. 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 Sterile Syringe, Disposable Sterile Syringe with Needle?

Disposable Sterile Syringe, Disposable Sterile Syringe with Needle is a medical device that received FDA 510(k) clearance on 2021-08-26. It is manufactured by Guangdong Antmed Co., Ltd.. The 510(k) number is K210991.

When was Disposable Sterile Syringe, Disposable Sterile Syringe with Needle approved by the FDA?

Disposable Sterile Syringe, Disposable Sterile Syringe with Needle received FDA 510(k) clearance on 2021-08-26, under approval number K210991.

What company makes Disposable Sterile Syringe, Disposable Sterile Syringe with Needle?

Disposable Sterile Syringe, Disposable Sterile Syringe with Needle is manufactured by Guangdong Antmed Co., Ltd..

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

The FDA product code for Disposable Sterile Syringe, Disposable Sterile 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 NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING 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 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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