# DEN230025: MIRA Surgical System

- Pathway: De Novo (Direct)
- Applicant: Virtual Incision
- Decided: Feb 23, 2024 after 318 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K260817: MIRA Surgical System (2026), 0 descendants of its own

## Indications for use
The MIRA Surgical System is a miniaturized robotic assisted surgery device indicated for the mobilization of the colon in adults at least 5’0” (1.52 m) tall and having a weight of at least 100 lbs (45.36 kg) who are undergoing minimally invasive colectomy procedures. It is intended to assist in the visualization of tissues and provide accurate and precise control of surgical instruments to grasp, retract, and dissect while maintaining hemostasis with electrocautery during manipulation of tissues. It is for prescription use only and is to be used by trained physicians in any operating room environment.

Source page: https://510kreport.com/device/DEN230025
Methodology: https://510kreport.com/methodology