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FDA 510(k)

Sterile Syringe with Fixed Safety Needle for Single Use

K-Number: K212652 · 2022-03-02

ApplicantGemtier Medical (Shanghai), Inc.
Decision Date2022-03-02
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Syringe with Fixed Safety Needle for Single Use is a medical device manufactured by Gemtier Medical (Shanghai), Inc.. It received FDA 510(k) clearance on 2022-03-02 under approval number K212652. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterile Syringe with Fixed Safety Needle for Single Use?

Sterile Syringe with Fixed Safety Needle for Single Use is a medical device that received FDA 510(k) clearance on 2022-03-02. It is manufactured by Gemtier Medical (Shanghai), Inc.. The 510(k) number is K212652.

When was Sterile Syringe with Fixed Safety Needle for Single Use approved by the FDA?

Sterile Syringe with Fixed Safety Needle for Single Use received FDA 510(k) clearance on 2022-03-02, under approval number K212652.

What company makes Sterile Syringe with Fixed Safety Needle for Single Use?

Sterile Syringe with Fixed Safety Needle for Single Use is manufactured by Gemtier Medical (Shanghai), Inc..

What is the FDA product code for Sterile Syringe with Fixed Safety Needle for Single Use?

The FDA product code for Sterile Syringe with Fixed Safety Needle for Single Use is MEG.

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Related PubMed Literature

PMID: 41810241 Diverging regulatory DNA in adaptive medical AI: US agility and EU accountability in lifecycle governance. Frontiers in medicine (2026) 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 Gemtier Medical (Shanghai), Inc.

K170276Safety Blood Collection Device for Single Use K192679Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use K202493Medical Face Mask K202331Medical Face Mask

Related Devices (Code: MEG)

K1620300.5ml Sol-Care Retractable Safety Syringe with Fixed NeedleSol-Millennium Medical, Inc. K152606Jeesung Safety Syringe and Single Use NeedlesJeesung Medical Co., Ltd. K152808U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd. K170651Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable NeedleYangzhou Medline Industry, Co., Ltd. K163162Sterile Hypodermic Safety Syringes for Single UseJiangxi Hongda Medical Equipment Group , Ltd. K163511NovaGuard SA Pro Safety SystemWest Pharmaceutical Services, 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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