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FDA 510(k)

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

K-Number: K211210 · 2022-01-27

ApplicantAzur Medical Company, Inc.
Decision Date2022-01-27
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Auto-Disable Syringes with/without Needle for Single Use is a medical device manufactured by Azur Medical Company, Inc.. It received FDA 510(k) clearance on 2022-01-27 under approval number K211210. 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 2022-01-27. It is manufactured by Azur Medical Company, Inc.. The 510(k) number is K211210.

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 2022-01-27, under approval number K211210.

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 Azur Medical Company, Inc..

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.

Related Clinical Trials

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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 Azur Medical Company, Inc.

K211214Sterile Hypodermic Needles for Single Use K211211Sterile syringes for single use with/without needle K231719Medical Surgical Mask

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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