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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / February 2026 / K254188

510(k) cleared

Meniscus Versaflex

GM Dos Reis Industria e Comercio Ltda. · Feb 19, 2026 · K254188

FDA cleared the Meniscus Versaflex from GM Dos Reis Industria e Comercio Ltda. on Feb 19, 2026 under K254188, 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 23, 2025. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

GM Dos Reis Industria e Comercio Ltda. has 4 other decisions in the tracker over the last 12 months: K261406 (Versalock Proximal Tibial Plating System), K260390 (Super Upper Limbs Versalock Plating System), K251050 (Pectus Versa System), K252664 (GMReis Suture Anchors).

Questions & Answers

What did FDA clear under K254188?

K254188 is the FDA 510(k) for Meniscus Versaflex, submitted by GM Dos Reis Industria e Comercio Ltda.. FDA's decision date was Feb 19, 2026, under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene).

Who makes the Meniscus Versaflex?

GM Dos Reis Industria e Comercio Ltda., based in Campinas, is the applicant of record for K254188.

How long did the K254188 review take?

FDA received the submission on Dec 23, 2025 and issued its decision on Feb 19, 2026, 58 days later.

← All decisions in February 2026

Sources