K243213
- 510(k) number
- K243213
- Device name
- Self-Forming Magnet (FLEX SFM)
- Applicant
- GI Windows, Inc. MA · US
- Product code
- SAH — Magnetic Compression Anastomosis System
- Decision date
- 2025-01-29
- Date received
- 2024-10-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243213.pdf
Official FDA record: K243213
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.