510(k) K222739

Disposable Insulin Pen Needle by Hantech Medical Device Co., Ltd. — Product Code FMI

K222739 is an FDA 510(k) premarket notification submitted by Hantech Medical Device Co., Ltd. for the device "Disposable Insulin Pen Needle". The FDA issued a decision of Substantially Equivalent on April 6, 2023. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Hantech Medical Device Co., Ltd. has at least 4 other 510(k) clearances on record.