Stitch - Suture Wires and Tapes— 510(k) K253910
Substantially EquivalentGM 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.
Summary
GM Dos Reis Industria e Comercio's Stitch - Suture Wires and Tapes is filed under product code GAT, nonabsorbable synthetic polyethylene sutures. The record gives no sizes or model numbers.
Class II, 21 CFR 878.5000. General and Plastic Surgery is both the classification panel and the review panel. It was a Traditional 510(k).
The applicant filed from Campinas, Brazil. The decision came 257 calendar days after FDA received it (December 8, 2025 to August 22, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- GM Dos Reis Industria e Comercio Ltda.
- Product code
- Product code GAT
- Device class
- Class 2
- Regulation
- 21 CFR 878.5000
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Campinas, BR
Recent devices under product code GAT
view allMore clearances from GM Dos Reis Industria e Comercio Ltda.
view allAdverse 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, through . 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.