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FDA 510(k)

Jeesung Safety Syringe and Single Use Needles

K-Number: K212518 · 2022-08-18

ApplicantJeesung Medical Co., Ltd.
Decision Date2022-08-18
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Jeesung Safety Syringe and Single Use Needles is a medical device manufactured by Jeesung Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-08-18 under approval number K212518. 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 Jeesung Safety Syringe and Single Use Needles?

Jeesung Safety Syringe and Single Use Needles is a medical device that received FDA 510(k) clearance on 2022-08-18. It is manufactured by Jeesung Medical Co., Ltd.. The 510(k) number is K212518.

When was Jeesung Safety Syringe and Single Use Needles approved by the FDA?

Jeesung Safety Syringe and Single Use Needles received FDA 510(k) clearance on 2022-08-18, under approval number K212518.

What company makes Jeesung Safety Syringe and Single Use Needles?

Jeesung Safety Syringe and Single Use Needles is manufactured by Jeesung Medical Co., Ltd..

What is the FDA product code for Jeesung Safety Syringe and Single Use Needles?

The FDA product code for Jeesung Safety Syringe and Single Use Needles is MEG.

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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) 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 Jeesung Medical Co., Ltd.

K152166JSM Insulin Pen Needle K152606Jeesung Safety Syringe and Single Use Needles

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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