K243482
- 510(k) number
- K243482
- Device name
- Self-Forming Magnet (Flexagon)
- Applicant
- GI Windows, Inc. MA · US
- Product code
- SAH — Magnetic Compression Anastomosis System
- Decision date
- 2025-06-11
- Date received
- 2024-11-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K243482.pdf
Official FDA record: K243482
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.