510(k) K253110

Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe by Sol-Millennium Medical, Inc. — Product Code FMF

K253110 is an FDA 510(k) premarket notification submitted by Sol-Millennium Medical, Inc. for the device "Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe". The FDA issued a decision of Substantially Equivalent on June 18, 2026. 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.