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FDA 510(k)

Insulin Syringe

K-Number: K230061 · 2023-11-30

Decision Date2023-11-30
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Insulin 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 2023-11-30 under 510(k) number K230061. 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 Insulin Syringe?

Insulin Syringe is a medical device that received FDA 510(k) clearance on 2023-11-30. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. The 510(k) number is K230061.

When did Insulin Syringe receive FDA 510(k) clearance?

Insulin Syringe received FDA 510(k) clearance on 2023-11-30, under 510(k) number K230061.

Who is the listed applicant for Insulin 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 Insulin Syringe?

The FDA product code for Insulin Syringe is FMF.

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: FMF)

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

View on FDA Database →

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