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The Tracker / September 2026 / K261467

510(k) cleared

GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01)

Gt Metabolic Solutions, Inc. · Sep 16, 2026 · K261467

FDA cleared the GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) from Gt Metabolic Solutions, Inc. on Sep 16, 2026 under K261467, 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 May 4, 2026. The decision came 135 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Gt Metabolic Solutions, Inc. has one other decision in the tracker over the last 12 months: K253102 (GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)).

Questions & Answers

What did FDA clear under K261467?

K261467 is the FDA 510(k) for GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01), submitted by Gt Metabolic Solutions, Inc.. FDA's decision date was Sep 16, 2026, under product code SAH (Magnetic Compression Anastomosis System).

Who makes the GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01)?

Gt Metabolic Solutions, Inc., based in St. Michael, MN, is the applicant of record for K261467.

How long did the K261467 review take?

FDA received the submission on May 4, 2026 and issued its decision on Sep 16, 2026, 135 days later.

← All decisions in September 2026

Sources