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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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.

Gt Metabolic Solutions, Inc. has one other decision in the tracker over the last 12 months: K261467 (GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01)).

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

Sources