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The Tracker / August 2026 / K253910

510(k) cleared

Stitch - Suture Wires and Tapes

GM Dos Reis Industria e Comercio Ltda. · Aug 22, 2026 · K253910

FDA cleared the Stitch - Suture Wires and Tapes from GM Dos Reis Industria e Comercio Ltda. on Aug 22, 2026 under K253910, a traditional 510(k). The device falls under product code GAT, Suture, Nonabsorbable, Synthetic, Polyethylene, regulated at 21 CFR 878.5000 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 8, 2025. The decision came 257 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

GM Dos Reis Industria e Comercio Ltda. has 6 other decisions in the tracker over the last 12 months: K262537 (Versalock Sterile Plating System), K261406 (Versalock Proximal Tibial Plating System), K260390 (Super Upper Limbs Versalock Plating System), K254188 (Meniscus Versaflex).

Questions & Answers

What did FDA clear under K253910?

K253910 is the FDA 510(k) for Stitch - Suture Wires and Tapes, submitted by GM Dos Reis Industria e Comercio Ltda.. FDA's decision date was Aug 22, 2026, under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene).

Who makes the Stitch - Suture Wires and Tapes?

GM Dos Reis Industria e Comercio Ltda., based in Campinas, is the applicant of record for K253910.

How long did the K253910 review take?

FDA received the submission on Dec 8, 2025 and issued its decision on Aug 22, 2026, 257 days later.

← All decisions in August 2026

Sources