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FDA 510(k)

U&U Insulin Syringe with/without Safety Retractable Device

K-Number: K152808 · 2016-03-25

ApplicantU&U Medical Technology Co, Ltd.
Decision Date2016-03-25
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

U&U Insulin Syringe with/without Safety Retractable Device is a medical device manufactured by U&U Medical Technology Co, Ltd.. It received FDA 510(k) clearance on 2016-03-25 under approval number K152808. 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 U&U Insulin Syringe with/without Safety Retractable Device?

U&U Insulin Syringe with/without Safety Retractable Device is a medical device that received FDA 510(k) clearance on 2016-03-25. It is manufactured by U&U Medical Technology Co, Ltd.. The 510(k) number is K152808.

When was U&U Insulin Syringe with/without Safety Retractable Device approved by the FDA?

U&U Insulin Syringe with/without Safety Retractable Device received FDA 510(k) clearance on 2016-03-25, under approval number K152808.

What company makes U&U Insulin Syringe with/without Safety Retractable Device?

U&U Insulin Syringe with/without Safety Retractable Device is manufactured by U&U Medical Technology Co, Ltd..

What is the FDA product code for U&U Insulin Syringe with/without Safety Retractable Device?

The FDA product code for U&U Insulin Syringe with/without Safety Retractable Device is MEG.

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Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026) PMID: 42065230 The need of innovation and of preservation of well-established techniques in the era of MDR for improving outcomes. EFORT open reviews (2026) PMID: 42024289 Signal Detection Using Change Point Analysis to Identify Safety Signals from Spontaneous Reports in Aortic Stent Grafts in Japan. Journal of medical systems (2026) PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026)

Other Devices by U&U Medical Technology Co, Ltd.

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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. 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. K180417Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single UseBerpu Medical Technology Co., Ltd.

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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