510(k) K243905

Stitch Cerclage – Suture Tapes by GM Dos Reis Industria e Comercio Ltda. — Product Code JDQ

K243905 is an FDA 510(k) premarket notification submitted by GM Dos Reis Industria e Comercio Ltda. for the device "Stitch Cerclage – Suture Tapes". The FDA issued a decision of Substantially Equivalent on August 14, 2025. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. GM Dos Reis Industria e Comercio Ltda. has at least 10 other 510(k) clearances on record.