510(k) K240774

Pen Injector by Wuxi Nest Biotechnology Co., Ltd. — Product Code FMF

K240774 is an FDA 510(k) premarket notification submitted by Wuxi Nest Biotechnology Co., Ltd. for the device "Pen Injector". The FDA issued a decision of Substantially Equivalent on June 18, 2024. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Wuxi Nest Biotechnology Co., Ltd. has at least 3 other 510(k) clearances on record.