510(k) K210059

Promisemed Insulin Pen Needle by Promisemed Hangzhou Meditech Co., Ltd. — Product Code FMI

K210059 is an FDA 510(k) premarket notification submitted by Promisemed Hangzhou Meditech Co., Ltd. for the device "Promisemed Insulin Pen Needle". The FDA issued a decision of Substantially Equivalent on Jul 21, 2021. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Promisemed Hangzhou Meditech Co., Ltd. has 35 other 510(k) clearances on record.