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FDA 510(k)

Sterile Safety Hypodermic Needles for Single Use

K-Number: K231723 · 2023-09-08

ApplicantWepon Medical Technology Co., Ltd.
Decision Date2023-09-08
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Safety Hypodermic Needles for Single Use is a medical device manufactured by Wepon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-09-08 under approval number K231723. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterile Safety Hypodermic Needles for Single Use?

Sterile Safety Hypodermic Needles for Single Use is a medical device that received FDA 510(k) clearance on 2023-09-08. It is manufactured by Wepon Medical Technology Co., Ltd.. The 510(k) number is K231723.

When was Sterile Safety Hypodermic Needles for Single Use approved by the FDA?

Sterile Safety Hypodermic Needles for Single Use received FDA 510(k) clearance on 2023-09-08, under approval number K231723.

What company makes Sterile Safety Hypodermic Needles for Single Use?

Sterile Safety Hypodermic Needles for Single Use is manufactured by Wepon Medical Technology Co., Ltd..

What is the FDA product code for Sterile Safety Hypodermic Needles for Single Use?

The FDA product code for Sterile Safety Hypodermic Needles for Single Use is FMI.

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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 Wepon Medical Technology Co., Ltd.

K212299Medical Surgical Mask K231727Sterile Auto-Disable Syringes with/without Needle for Single Use K231729Sterile syringes for single use with/without needle K231720Sterile Hypodermic Needles for Single Use

Related Devices (Code: FMI)

K162516BD Pen NeedleBecton, Dickinson and Company K160532Greiner HoldexGreiner Bio-One Na, Inc. K160199Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc. K151090CPL Insulin Pen NeedleCpl Co., Ltd. K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc. K153706Insulin Pen NeedleSteriLance Medical (Suzhou), 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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