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FDA 510(k)

Sterile hypodermic syringes for single use

K-Number: K211728 · 2021-10-05

ApplicantJiangsu Kangyou Medical Instrument Co., Ltd.
Decision Date2021-10-05
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile hypodermic syringes for single use is a medical device manufactured by Jiangsu Kangyou Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2021-10-05 under approval number K211728. 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 hypodermic syringes for single use?

Sterile hypodermic syringes for single use is a medical device that received FDA 510(k) clearance on 2021-10-05. It is manufactured by Jiangsu Kangyou Medical Instrument Co., Ltd.. The 510(k) number is K211728.

When was Sterile hypodermic syringes for single use approved by the FDA?

Sterile hypodermic syringes for single use received FDA 510(k) clearance on 2021-10-05, under approval number K211728.

What company makes Sterile hypodermic syringes for single use?

Sterile hypodermic syringes for single use is manufactured by Jiangsu Kangyou Medical Instrument Co., Ltd..

What is the FDA product code for Sterile hypodermic syringes for single use?

The FDA product code for Sterile hypodermic syringes for single use is FMF.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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