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FDA 510(k)

Sterile Hypodermic Needle for Single Use

K-Number: K180259 · 2018-05-18

ApplicantJiangsu Shenli Medical Production Co., Ltd.
Decision Date2018-05-18
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Hypodermic Needle for Single Use is a medical device manufactured by Jiangsu Shenli Medical Production Co., Ltd.. It received FDA 510(k) clearance on 2018-05-18 under approval number K180259. 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 Needle for Single Use?

Sterile Hypodermic Needle for Single Use is a medical device that received FDA 510(k) clearance on 2018-05-18. It is manufactured by Jiangsu Shenli Medical Production Co., Ltd.. The 510(k) number is K180259.

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

Sterile Hypodermic Needle for Single Use received FDA 510(k) clearance on 2018-05-18, under approval number K180259.

What company makes Sterile Hypodermic Needle for Single Use?

Sterile Hypodermic Needle for Single Use is manufactured by Jiangsu Shenli Medical Production Co., Ltd..

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

The FDA product code for Sterile Hypodermic Needle 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 Jiangsu Shenli Medical Production Co., Ltd.

K163093Safety Blood Collection Set K200557Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)

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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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