510(k) K240961

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

K240961 is an FDA 510(k) premarket notification submitted by Wuxi Nest Biotechnology Co., Ltd. for the device "Disposable Pen Injector Assembly". The FDA issued a decision of Substantially Equivalent on August 15, 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.