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FDA 510(k)

Sterile Syringe for Single Use

K-Number: K210914 · 2021-12-17

ApplicantJiangsu Suyun Medical Material Co., Ltd.
Decision Date2021-12-17
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Syringe for Single Use is a medical device manufactured by Jiangsu Suyun Medical Material Co., Ltd.. It received FDA 510(k) clearance on 2021-12-17 under approval number K210914. 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 Syringe for Single Use?

Sterile Syringe for Single Use is a medical device that received FDA 510(k) clearance on 2021-12-17. It is manufactured by Jiangsu Suyun Medical Material Co., Ltd.. The 510(k) number is K210914.

When was Sterile Syringe for Single Use approved by the FDA?

Sterile Syringe for Single Use received FDA 510(k) clearance on 2021-12-17, under approval number K210914.

What company makes Sterile Syringe for Single Use?

Sterile Syringe for Single Use is manufactured by Jiangsu Suyun Medical Material Co., Ltd..

What is the FDA product code for Sterile Syringe for Single Use?

The FDA product code for Sterile Syringe 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)

Related Devices (Code: FMF)

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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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