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FDA 510(k)

Sterile Hypodermic Needles for Single Use

K-Number: K210232 · 2021-09-23

ApplicantZhejiang Kangkang Medical-Devices Co., Ltd.
Decision Date2021-09-23
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Hypodermic Needles for Single Use is a medical device manufactured by Zhejiang Kangkang Medical-Devices Co., Ltd.. It received FDA 510(k) clearance on 2021-09-23 under approval number K210232. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterile Hypodermic Needles for Single Use?

Sterile Hypodermic Needles for Single Use is a medical device that received FDA 510(k) clearance on 2021-09-23. It is manufactured by Zhejiang Kangkang Medical-Devices Co., Ltd.. The 510(k) number is K210232.

When was Sterile Hypodermic Needles for Single Use approved by the FDA?

Sterile Hypodermic Needles for Single Use received FDA 510(k) clearance on 2021-09-23, under approval number K210232.

What company makes Sterile Hypodermic Needles for Single Use?

Sterile Hypodermic Needles for Single Use is manufactured by Zhejiang Kangkang Medical-Devices Co., Ltd..

What is the FDA product code for Sterile Hypodermic Needles for Single Use?

The FDA product code for Sterile Hypodermic Needles for Single Use is FMI.

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.

K210227Sterile syringe for single use with/without needle K213535Sterile Safety Hypodermic Needles for Single Use K210229Sterile Auto-Disable Syringes with/without Needle for Single Use

Related Devices (Code: FMI)

K162516BD Pen NeedleBecton, Dickinson and Company K160532Greiner HoldexGreiner Bio-One Na, Inc. K160199Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc. K151090CPL Insulin Pen NeedleCpl Co., Ltd. K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc. K153706Insulin Pen NeedleSteriLance Medical (Suzhou), 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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