DEN240013
- 510(k) number
- DEN240013
- Device name
- MagDI System
- Applicant
- Gt Metabolic Solutions, Inc. CA · US
- Product code
- SAH — Magnetic Compression Anastomosis System
- Decision date
- 2024-07-02
- Date received
- 2024-03-26
- Decision
- Unknown
- Clearance type
- Post-NSE
- Advisory committee
- General, Plastic Surgery
Official FDA record: DEN240013
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.