Disposable Insulin Pen Needle
K-Number: K221178 · 2022-11-17
ApplicantNingbo Medsun Medical Co., Ltd.
Decision Date2022-11-17
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Disposable Insulin Pen Needle is a medical device manufactured by Ningbo Medsun Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-11-17 under approval number K221178. 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 Disposable Insulin Pen Needle?
Disposable Insulin Pen Needle is a medical device that received FDA 510(k) clearance on 2022-11-17. It is manufactured by Ningbo Medsun Medical Co., Ltd.. The 510(k) number is K221178.
When was Disposable Insulin Pen Needle approved by the FDA?
Disposable Insulin Pen Needle received FDA 510(k) clearance on 2022-11-17, under approval number K221178.
What company makes Disposable Insulin Pen Needle?
Disposable Insulin Pen Needle is manufactured by Ningbo Medsun Medical Co., Ltd..
What is the FDA product code for Disposable Insulin Pen Needle?
The FDA product code for Disposable Insulin Pen Needle is FMI.
Related Clinical Trials
Other Devices by Ningbo Medsun Medical Co., Ltd.
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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.