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FDA 510(k)

Sterile Hypodermic Needles for Single Use

K-Number: K211214 · 2021-10-14

ApplicantAzur Medical Company, Inc.
Decision Date2021-10-14
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Hypodermic Needles for Single Use is a medical device manufactured by Azur Medical Company, Inc.. It received FDA 510(k) clearance on 2021-10-14 under approval number K211214. 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 Hypodermic Needles for Single Use?

Sterile Hypodermic Needles for Single Use is a medical device that received FDA 510(k) clearance on 2021-10-14. It is manufactured by Azur Medical Company, Inc.. The 510(k) number is K211214.

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

Sterile Hypodermic Needles for Single Use received FDA 510(k) clearance on 2021-10-14, under approval number K211214.

What company makes Sterile Hypodermic Needles for Single Use?

Sterile Hypodermic Needles for Single Use is manufactured by Azur Medical Company, Inc..

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

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

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.

K211211Sterile syringes for single use with/without needle K211210Sterile Auto-Disable Syringes with/without Needle for Single Use K231719Medical Surgical Mask

Related Devices (Code: FMI)

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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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