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FDA 510(k)

Sterile Safety Hypodermic Needles for Single Use

K-Number: K213535 · 2022-05-13

ApplicantZhejiang Kangkang Medical-Devices Co., Ltd.
Decision Date2022-05-13
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Safety Hypodermic Needles for Single Use is a medical device manufactured by Zhejiang Kangkang Medical-Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-05-13 under approval number K213535. 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 Safety Hypodermic Needles for Single Use?

Sterile Safety Hypodermic Needles for Single Use is a medical device that received FDA 510(k) clearance on 2022-05-13. It is manufactured by Zhejiang Kangkang Medical-Devices Co., Ltd.. The 510(k) number is K213535.

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

Sterile Safety Hypodermic Needles for Single Use received FDA 510(k) clearance on 2022-05-13, under approval number K213535.

What company makes Sterile Safety Hypodermic Needles for Single Use?

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

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

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

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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) PMID: 41090443 Confirmatory evidence supporting single pivotal trial new drug approvals by the Food and Drug Administration, 2015 through 2023. Clinical trials (London, England) (2026)

Other Devices by Zhejiang Kangkang Medical-Devices Co., Ltd.

K210232Sterile Hypodermic Needles for Single Use K210227Sterile syringe for single use with/without needle 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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