510(k) K222672

Disposable Insulin Syringe by Hantech Medical Device Co., Ltd. — Product Code FMF

K222672 is an FDA 510(k) premarket notification submitted by Hantech Medical Device Co., Ltd. for the device "Disposable Insulin Syringe". The FDA issued a decision of Substantially Equivalent on March 6, 2023. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Hantech Medical Device Co., Ltd. has at least 4 other 510(k) clearances on record.