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FDA 510(k)

Sterile Auto-Disable Syringes with/without Needle for Single Use

K-Number: K231727 · 2023-09-08

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

Device Summary

Sterile Auto-Disable Syringes with/without Needle 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 K231727. 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 Auto-Disable Syringes with/without Needle for Single Use?

Sterile Auto-Disable Syringes with/without Needle 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 K231727.

When was Sterile Auto-Disable Syringes with/without Needle for Single Use approved by the FDA?

Sterile Auto-Disable Syringes with/without Needle for Single Use received FDA 510(k) clearance on 2023-09-08, under approval number K231727.

What company makes Sterile Auto-Disable Syringes with/without Needle for Single Use?

Sterile Auto-Disable Syringes with/without Needle for Single Use is manufactured by Wepon Medical Technology Co., Ltd..

What is the FDA product code for Sterile Auto-Disable Syringes with/without Needle for Single Use?

The FDA product code for Sterile Auto-Disable Syringes with/without Needle 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)

Other Devices by Wepon Medical Technology Co., Ltd.

K212299Medical Surgical Mask K231723Sterile Safety Hypodermic Needles for Single Use K231729Sterile syringes for single use with/without needle K231720Sterile Hypodermic Needles for Single Use

Related Devices (Code: FMF)

K162180Disposable Insulin SyringeBerpu Medical Technology Co., Ltd. K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin SyringeBecton, Dickinson and Company K162602NovoPen EchoNovo Nordisk, Inc. K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. K152879Sure-Fine Insulin SyringesShina Med Corporation K160629InPenCompanion Medical, 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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