510(k) K254188

Meniscus Versaflex by GM Dos Reis Industria e Comercio Ltda. — Product Code GAT

K254188 is an FDA 510(k) premarket notification submitted by GM Dos Reis Industria e Comercio Ltda. for the device "Meniscus Versaflex". The FDA issued a decision of Substantially Equivalent on February 19, 2026. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. GM Dos Reis Industria e Comercio Ltda. has at least 10 other 510(k) clearances on record.