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FDA 510(k)

Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe

K-Number: K190183 · 2019-10-04

Decision Date2019-10-04
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe 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 2019-10-04 under 510(k) number K190183. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe?

Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe is a medical device that received FDA 510(k) clearance on 2019-10-04. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. The 510(k) number is K190183.

When did Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe receive FDA 510(k) clearance?

Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe received FDA 510(k) clearance on 2019-10-04, under 510(k) number K190183.

Who is the listed applicant for Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe?

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 Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe?

The FDA product code for Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe is MEG.

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: MEG)

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.