Safety Pen Needle
K-Number: K253622 · 2026-03-18
ApplicantNingbo Medsun Medical Co., Ltd.
Decision Date2026-03-18
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Safety Pen Needle is a medical device manufactured by Ningbo Medsun Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-03-18 under approval number K253622. 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 Safety Pen Needle?
Safety Pen Needle is a medical device that received FDA 510(k) clearance on 2026-03-18. It is manufactured by Ningbo Medsun Medical Co., Ltd.. The 510(k) number is K253622.
When was Safety Pen Needle approved by the FDA?
Safety Pen Needle received FDA 510(k) clearance on 2026-03-18, under approval number K253622.
What company makes Safety Pen Needle?
Safety Pen Needle is manufactured by Ningbo Medsun Medical Co., Ltd..
What is the FDA product code for Safety Pen Needle?
The FDA product code for Safety Pen Needle is FMI.
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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.