Disposable Insulin Pen Needle
K-Number: K222739 · 2023-04-06
Device Summary
Frequently Asked Questions
What is the Disposable Insulin Pen Needle?
Disposable Insulin Pen Needle is a medical device that received FDA 510(k) clearance on 2023-04-06. The listed applicant is Hantech Medical Device Co., Ltd.. The 510(k) number is K222739.
When did Disposable Insulin Pen Needle receive FDA 510(k) clearance?
Disposable Insulin Pen Needle received FDA 510(k) clearance on 2023-04-06, under 510(k) number K222739.
Who is the listed applicant for Disposable Insulin Pen Needle?
The FDA 510(k) record lists Hantech Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Disposable Insulin Pen Needle?
The FDA product code for Disposable Insulin Pen Needle is FMI.
Other records listing Hantech Medical Device 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.