510(k) K253024

ProZip Knotless Implant by Riverpoint Medical — Product Code GAT

K253024 is an FDA 510(k) premarket notification submitted by Riverpoint Medical for the device "ProZip Knotless Implant". The FDA issued a decision of Substantially Equivalent on October 16, 2025. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Riverpoint Medical has at least 10 other 510(k) clearances on record.