Stitch - Suture Wires and Tapes— 510(k) K253910

Name: FDA 510(k) clearance K253910
Creator: U.S. Food and Drug Administration
Published: 2026-08-22

Substantially Equivalent

GM Dos Reis Industria e Comercio Ltda.

FDA 510(k) clearance K253910 for Stitch - Suture Wires and Tapes, Substantially Equivalent on 2026-08-22. Applicant: GM Dos Reis Industria e Comercio Ltda.. Device class: 2.

Clearance details

Applicant: GM Dos Reis Industria e Comercio Ltda.
Product code: Code GAT
Device class: Class 2
Regulation: 21 CFR 878.5000
Advisory panel: General, Plastic Surgery
Date received: 2025-12-08
Decision date: 2026-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Campinas, BR

Download summary PDF View on FDA.gov ↗

Recent devices under product code GAT

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K261021 — EasyWhip Family2026-07-01
K260775 — Polyethylene; Polyethylene Fusion; Polyethylene OrthoTape2026-05-06
K254275 — HyperSuture All Green Extension Line2026-03-23
K254188 — Meniscus Versaflex2026-02-19
K253145 — Pre-Sutured Tendon2025-10-22

More clearances from GM Dos Reis Industria e Comercio Ltda.

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K262537 — Versalock Sterile Plating System2026-08-19
K261406 — Versalock Proximal Tibial Plating System2026-07-21
K260390 — Super Upper Limbs Versalock Plating System2026-03-17
K252664 — GMReis Suture Anchors2025-11-04
K243905 — Stitch Cerclage Suture Tapes2025-08-14

Adverse events under product code GAT

product code GAT

Death: 19
Injury: 4,163
Malfunction: 8,646
Other: 2
Total: 12,830

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.