Device Atlas

MIRA Surgical System

Q: What is the product code of K260817?

The FDA product code is SAB – Table Mounted Miniaturized Electromechanical Surgical System, a Class II (moderate risk) device regulated under 21 CFR 878.4962.

FDA 510(k) K260817 · Virtual Incision

Substantially Equivalent

510(k) numberK260817

Submission

Device name: MIRA Surgical System
Applicant: Virtual Incision
Lincoln, NE, US
Received: March 13, 2026
Decision date: August 20, 2026
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: SAB – Table Mounted Miniaturized Electromechanical Surgical System
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.4962
Specialty: General, Plastic Surgery

A table mounted miniaturized electromechanical surgical system is a software-controlled electromechanical system with surgical table mounted patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures where the software-controlled electromechanical devices miniaturized and compact size allows the effective element of the…

Questions and answers

When was MIRA Surgical System cleared by the FDA?

MIRA Surgical System (K260817) received a 510(k) decision of Substantially Equivalent on August 20, 2026, 160 days after the submission was received.

What is the product code of K260817?

The FDA product code is SAB – Table Mounted Miniaturized Electromechanical Surgical System, a Class II (moderate risk) device regulated under 21 CFR 878.4962.