K243359
- 510(k) number
- K243359
- Device name
- MagDI System (MAG-02, DS-01)
- Applicant
- Gt Metabolic Solutions, Inc. CA · US
- Product code
- SAH — Magnetic Compression Anastomosis System
- Decision date
- 2025-02-28
- Date received
- 2024-10-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K243359.pdf
Official FDA record: K243359
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.