510(k) K220713

Sol-Guard Auto-disable Syringe by Sol-Millennium Medical, Inc. — Product Code FMF

K220713 is an FDA 510(k) premarket notification submitted by Sol-Millennium Medical, Inc. for the device "Sol-Guard Auto-disable Syringe". The FDA issued a decision of Substantially Equivalent on May 4, 2023. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Sol-Millennium Medical, Inc. has at least 10 other 510(k) clearances on record.