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FDA 510(k)

Sterile syringe for single use with/without needle

K-Number: K210227 · 2021-09-10

ApplicantZhejiang Kangkang Medical-Devices Co., Ltd.
Decision Date2021-09-10
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile syringe for single use with/without needle is a medical device manufactured by Zhejiang Kangkang Medical-Devices Co., Ltd.. It received FDA 510(k) clearance on 2021-09-10 under approval number K210227. 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/without needle?

Sterile syringe for single use with/without needle is a medical device that received FDA 510(k) clearance on 2021-09-10. It is manufactured by Zhejiang Kangkang Medical-Devices Co., Ltd.. The 510(k) number is K210227.

When was Sterile syringe for single use with/without needle approved by the FDA?

Sterile syringe for single use with/without needle received FDA 510(k) clearance on 2021-09-10, under approval number K210227.

What company makes Sterile syringe for single use with/without needle?

Sterile syringe for single use with/without needle is manufactured by Zhejiang Kangkang Medical-Devices Co., Ltd..

What is the FDA product code for Sterile syringe for single use with/without needle?

The FDA product code for Sterile syringe for single use with/without 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 Zhejiang Kangkang Medical-Devices Co., Ltd.

K210232Sterile Hypodermic Needles for Single Use K213535Sterile Safety Hypodermic Needles for Single Use K210229Sterile Auto-Disable Syringes with/without Needle for Single Use

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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