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FDA 510(k)

Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle

K-Number: K222124 · 2022-11-04

Decision Date2022-11-04
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2022-11-04 under 510(k) number K222124. 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 Syringe with/without Needle, Hypodermic Needle?

Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle is a medical device that received FDA 510(k) clearance on 2022-11-04. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. The 510(k) number is K222124.

When did Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle receive FDA 510(k) clearance?

Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle received FDA 510(k) clearance on 2022-11-04, under 510(k) number K222124.

Who is the listed applicant for Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle?

The FDA 510(k) record lists Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle?

The FDA product code for Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle is FMI.

Other records listing Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 12 devices →

Related Devices (Code: FMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.