K253102
- 510(k) number
- K253102
- Device name
- GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)
- Applicant
- Gt Metabolic Solutions, Inc. MN · US
- Product code
- SAH — Magnetic Compression Anastomosis System
- Decision date
- 2026-06-04
- Date received
- 2025-09-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K253102.pdf
Official FDA record: K253102
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.