GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)— 510(k) K253102

Name: FDA 510(k) clearance K253102
Creator: U.S. Food and Drug Administration
Published: 2026-06-04

Substantially Equivalent

Gt Metabolic Solutions, Inc.

FDA 510(k) clearance K253102 for GT Metabolic MagDI System (MAG-01, MAG-02, DS-01), Substantially Equivalent on 2026-06-04. Applicant: Gt Metabolic Solutions, Inc.. Device class: 2.

Clearance details

Applicant: Gt Metabolic Solutions, Inc.
Product code: Code SAH
Device class: Class 2
Regulation: 21 CFR 878.4816
Advisory panel: General, Plastic Surgery
Date received: 2025-09-24
Decision date: 2026-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Michael, MN, US

Download summary PDF View on FDA.gov ↗

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