510(k) K251089

EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle by Exelint International, Co. — Product Code FMF

K251089 is an FDA 510(k) premarket notification submitted by Exelint International, Co. for the device "EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle". The FDA issued a decision of Substantially Equivalent on Dec 12, 2025. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Exelint International, Co. has at least 6 other 510(k) clearances on record.