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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 / June 2026 / K253102

510(k) cleared

GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)

Gt Metabolic Solutions, Inc. · Jun 4, 2026 · K253102

FDA cleared the GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) from Gt Metabolic Solutions, Inc. on Jun 4, 2026 under K253102, a traditional 510(k). The device falls under product code SAH, Magnetic Compression Anastomosis System, regulated at 21 CFR 878.4816 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 24, 2025. The decision came 253 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Gt Metabolic Solutions, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253102?

K253102 is the FDA 510(k) for GT Metabolic MagDI System (MAG-01, MAG-02, DS-01), submitted by Gt Metabolic Solutions, Inc.. FDA's decision date was Jun 4, 2026, under product code SAH (Magnetic Compression Anastomosis System).

Who makes the GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)?

Gt Metabolic Solutions, Inc., based in St. Michael, MN, is the applicant of record for K253102.

How long did the K253102 review take?

FDA received the submission on Sep 24, 2025 and issued its decision on Jun 4, 2026, 253 days later.

← All decisions in June 2026