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FDA 510(k)

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

K-Number: K253102 · 2026-06-04

ApplicantGt Metabolic Solutions, Inc.
Decision Date2026-06-04
Product CodeSAH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GT Metabolic MagDI System (MAG-01, MAG-02, 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 2026-06-04 under 510(k) number K253102. The device is classified under product code SAH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)?

GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) is a medical device that received FDA 510(k) clearance on 2026-06-04. The listed applicant is Gt Metabolic Solutions, Inc.. The 510(k) number is K253102.

When did GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) receive FDA 510(k) clearance?

GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) received FDA 510(k) clearance on 2026-06-04, under 510(k) number K253102.

Who is the listed applicant for GT Metabolic MagDI System (MAG-01, MAG-02, 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 MagDI System (MAG-01, MAG-02, DS-01)?

The FDA product code for GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) is SAH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06467955MagDI Canada StudyACTIVE_NOT_RECRUITINGNCT06473831MagDI Australia StudyACTIVE_NOT_RECRUITINGNCT06613711MagDI Italian StudyCOMPLETEDNCT06073457Magnetic Gastro-Ileal or Gastro-Jejunal Diversion Study ("MGI/MGJ Study")ACTIVE_NOT_RECRUITINGNCT07317076GT Metabolic Magnet System in Adults With Gastrointestinal DisordersRECRUITINGNCT07317115Side-to-Side Duodeno-ileostomy Versus Semaglutide in Adults With Obesity and Type 2 DiabetesRECRUITING

Other records listing Gt Metabolic Solutions, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243359MagDI System (MAG-02, DS-01)K242086MagDI System (MAG-01, DS-01)

Related Devices (Code: SAH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.K242086MagDI System (MAG-01, DS-01)Gt Metabolic Solutions, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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