FDA 510(k)

MagDI System (MAG-02, DS-01)

K-Number: K243359 · 2025-02-28

Decision Date2025-02-28

Product CodeSAH

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MagDI System (MAG-02, DS-01) is a medical device manufactured by Gt Metabolic Solutions, Inc.. It received FDA 510(k) clearance on 2025-02-28 under approval number K243359. 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 MagDI System (MAG-02, DS-01)?

MagDI System (MAG-02, DS-01) is a medical device that received FDA 510(k) clearance on 2025-02-28. It is manufactured by Gt Metabolic Solutions, Inc.. The 510(k) number is K243359.

When was MagDI System (MAG-02, DS-01) approved by the FDA?

MagDI System (MAG-02, DS-01) received FDA 510(k) clearance on 2025-02-28, under approval number K243359.

What company makes MagDI System (MAG-02, DS-01)?

MagDI System (MAG-02, DS-01) is manufactured by Gt Metabolic Solutions, Inc..

What is the FDA product code for MagDI System (MAG-02, DS-01)?

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

Related Clinical Trials

NCT06467955 MagDI Canada Study ACTIVE_NOT_RECRUITING NCT06473831 MagDI Australia Study ACTIVE_NOT_RECRUITING NCT06613711 MagDI Italian Study COMPLETED

Related Devices (Code: SAH)

K242086MagDI System (MAG-01, DS-01)Gt Metabolic Solutions, Inc. DEN240013MagDI SystemGt Metabolic Solutions, Inc. K250541Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc. K243482Self-Forming Magnet (Flexagon)GI Windows, Inc. K243213Self-Forming Magnet (FLEX SFM)GI Windows, Inc. K253550Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc.

Official Source

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