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FDA 510(k)

Sterile Hypodermic Needles for Single Use

K-Number: K233037 · 2023-12-12

ApplicantZhejiang Kindly Medical Device Co., Ltd.
Decision Date2023-12-12
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Hypodermic Needles for Single Use is a medical device manufactured by Zhejiang Kindly Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2023-12-12 under approval number K233037. 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 2023-12-12. It is manufactured by Zhejiang Kindly Medical Device Co., Ltd.. The 510(k) number is K233037.

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

Sterile Hypodermic Needles for Single Use received FDA 510(k) clearance on 2023-12-12, under approval number K233037.

What company makes Sterile Hypodermic Needles for Single Use?

Sterile Hypodermic Needles for Single Use is manufactured by Zhejiang Kindly Medical Device 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.

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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)

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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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