K260817
- 510(k) number
- K260817
- Device name
- MIRA Surgical System
- Applicant
- Virtual Incision NE · US
- Product code
- SAB — Table Mounted Miniaturized Electromechanical Surgica
- Decision date
- 2026-08-20
- Date received
- 2026-03-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K260817.pdf
Official FDA record: K260817
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.