510(k) clearance

MIRA Surgical System

FDA 510(k) source

510(k) number

K260817

Applicant

Virtual Incision

Decision date

Aug 20, 2026

Date received

Mar 13, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

SAB

Device type

Table Mounted Miniaturized Electromechanical Surgical System

Device class

Class II

Regulation

21 CFR 878.4962

Advisory committee

General, Plastic Surgery

Statement or summary

Summary

Third party

N

Location

Lincoln, NE, US