FDA 510(k)

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

K-Nummer: K261467 · 2026-09-16

AntragstellerGt Metabolic Solutions, Inc.

Entscheidungsdatum2026-09-16

ProduktcodeSAH

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) is the device name listed in this FDA 510(k) record. The listed applicant is Gt Metabolic Solutions, Inc.. It received FDA 510(k) clearance on 2026-09-16 under 510(k) number K261467. The device is classified under product code SAH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01)?

GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is Gt Metabolic Solutions, Inc.. The 510(k) number is K261467.

When did GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) receive FDA 510(k) clearance?

GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) received FDA 510(k) clearance on 2026-09-16, under 510(k) number K261467.

Who is the listed applicant for GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01)?

The FDA 510(k) record lists Gt Metabolic Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01)?

The FDA product code for GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) is SAH.

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Weitere Einträge mit Gt Metabolic Solutions, Inc. als Antragsteller

K253102GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)K243359MagDI System (MAG-02, DS-01)K242086MagDI System (MAG-01, DS-01)

Verwandte Geräte (Code: SAH)

K253102GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)Gt Metabolic Solutions, Inc.K253550Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc.K250541Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc.K243482Self-Forming Magnet (Flexagon)GI Windows, Inc.K243359MagDI System (MAG-02, DS-01)Gt Metabolic Solutions, Inc.K243213Self-Forming Magnet (FLEX SFM)GI Windows, Inc.

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