Meniscus Versaflex— 510(k) K254188
Substantially EquivalentGM Dos Reis Industria e Comercio Ltda.
FDA 510(k) clearance K254188 for Meniscus Versaflex, Substantially Equivalent on 2026-02-19. Applicant: GM Dos Reis Industria e Comercio Ltda.. Device class: 2.
Summary
GM Dos Reis Industria e Comercio's Meniscus Versaflex is filed under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene). The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 878.5000. The Orthopedic review panel handled it as a Traditional 510(k), though the record lists General, Plastic Surgery as the classification panel.
GM Dos Reis filed from Campinas, Brazil. The decision came 58 calendar days after FDA received it (December 23, 2025 to February 19, 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.