# K260817: MIRA Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Virtual Incision
- Decided: Aug 20, 2026 after 160 days
- Product code: SAB (Table Mounted Miniaturized Electromechanical Surgical System)
- Device class: 2
- Regulation: 21 CFR 878.4962
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN230025 (2024). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN230025: MIRA Surgical System, Virtual Incision (2024) Summary page 5.

## Indications for use
The MIRA Surgical System is a miniaturized robotic assisted surgery device intended to assist in the visualization of tissues and provide accurate and precise control of surgical instruments to grasp, retract, dissect, and suture while maintaining hemostasis with electrocautery during manipulation of tissues. The device is indicated for mobilization of the colon during minimally invasive colectomy in adults at least 5'0" (1.52 m) tall and having a weight of at least 100 lbs (45.36 kg). The MIRA Surgical System is also indicated for minimally invasive benign (sub-) total hysterectomy with or without salpingectomy in adults with a uterine size not exceeding 12 cm longitudinally on imaging, at least 5'0" (1.52 m) tall and having a weight of at least 100 lbs (45.36 kg), and a BMI less than 40kg/m2. It is for prescription use only and is to be used by trained physicians in any operating room environment in accordance with the representative surgical procedures listed in the MIRA Surgical System User Manual.

Source page: https://510kreport.com/device/K260817
Methodology: https://510kreport.com/methodology