WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / November 2025 / K252664

510(k) cleared

GMReis Suture Anchors

GM Dos Reis Industria e Comercio Ltda. · Nov 4, 2025 · K252664

FDA cleared the GMReis Suture Anchors from GM Dos Reis Industria e Comercio Ltda. on Nov 4, 2025 under K252664, a traditional 510(k). The device falls under product code MBI, Fastener, Fixation, Nondegradable, Soft Tissue, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 22, 2025. The decision came 74 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), K254188 (Meniscus Versaflex), K251050 (Pectus Versa System).

Questions & Answers

What did FDA clear under K252664?

K252664 is the FDA 510(k) for GMReis Suture Anchors, submitted by GM Dos Reis Industria e Comercio Ltda.. FDA's decision date was Nov 4, 2025, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the GMReis Suture Anchors?

GM Dos Reis Industria e Comercio Ltda., based in Campinas, is the applicant of record for K252664.

How long did the K252664 review take?

FDA received the submission on Aug 22, 2025 and issued its decision on Nov 4, 2025, 74 days later.

← All decisions in November 2025

Sources