K252740
- 510(k) number
- K252740
- Device name
- Voyant® Open Fusion Device (EB240/Open Fusion)
- Applicant
- Applied Medical Resources Corp. CA · US
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2025-11-04
- Date received
- 2025-08-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K252740.pdf
Official FDA record: K252740
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.