K250541
- 510(k) number
- K250541
- Device name
- Self-Forming Magnet (Flexagon Plus OTOLoc)
- Applicant
- GI Windows, Inc. MA · US
- Product code
- SAH — Magnetic Compression Anastomosis System
- Decision date
- 2025-08-01
- Date received
- 2025-02-24
- 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: K250541.pdf
Official FDA record: K250541
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.