510(k) K223453

Insulin Syringe by Promisemed Hangzhou Meditech Co., Ltd. — Product Code FMF

K223453 is an FDA 510(k) premarket notification submitted by Promisemed Hangzhou Meditech Co., Ltd. for the device "Insulin Syringe". The FDA issued a decision of Substantially Equivalent on March 2, 2023. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Promisemed Hangzhou Meditech Co., Ltd. has at least 10 other 510(k) clearances on record.