Class Class II
MagDI System (MAG-01, DS-01) (K242086)
Description
MagDI System (MAG-01, DS-01) by Gt Metabolic Solutions, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242086
Clearance Date2024-10-24
Clearance TypeTraditional
Product CodeSAH
Regulation Number878.4816
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242086
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. MagDI System (MAG-01, DS-01) (K242086) cites 0 predicate devices and is itself cited by 1 later device.
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243359 | MagDI System (MAG-02, DS-01) | Gt Metabolic Solutions, Inc. | 2025 |
Trace the full predicate network for K242086
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.