Clearance Summary
MagDI System received FDA 510(k) clearance under submission number DEN240013, sponsored by Gt Metabolic Solutions, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2024-07-02.
- Submission: DEN240013
- Applicant / Sponsor: Gt Metabolic Solutions, Inc.
- Clearance pathway: Post-NSE
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4816
- Decision date: 2024-07-02
Classification & Regulation
This clearance is catalogued under FDA product code SAH and 21 CFR 878.4816, within the General, Plastic Surgery review panel as a Class II device.