Insulin Pen Needle
K-Number: K230043 · 2023-09-20
Device Summary
Frequently Asked Questions
What is the Insulin Pen Needle?
Insulin Pen Needle is a medical device that received FDA 510(k) clearance on 2023-09-20. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. The 510(k) number is K230043.
When did Insulin Pen Needle receive FDA 510(k) clearance?
Insulin Pen Needle received FDA 510(k) clearance on 2023-09-20, under 510(k) number K230043.
Who is the listed applicant for Insulin Pen 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 Insulin Pen Needle?
The FDA product code for Insulin Pen 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.
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.