MIRA Surgical System— 510(k) K260817
Substantially EquivalentVirtual Incision
FDA 510(k) clearance K260817 for MIRA Surgical System, Substantially Equivalent on 2026-08-20. Applicant: Virtual Incision. Device class: 2.
Summary
Virtual Incision's MIRA Surgical System is filed under product code SAB, table mounted miniaturized electromechanical surgical systems. The record doesn't expand MIRA or describe the system further.
Class II, 21 CFR 878.4962. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Virtual Incision filed from Lincoln, Nebraska. The decision came 160 calendar days after FDA received it (March 13 to August 20, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Virtual Incision
- Product code
- Product code SAB
- Device class
- Class 2
- Regulation
- 21 CFR 878.4962
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lincoln, NE, US
Recent devices under product code SAB
view allData sourced from openFDA. This site is unofficial and independent of the FDA.