510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN230025Unknown

MIRA Surgical System

Virtual Incision Corporation, Lincoln NE / Direct, Unknown
FDA source (opens on fda.gov)

DEN230025 is the FDA 510(k) clearance record for MIRA Surgical System, a class II device, cleared for Virtual Incision on under FDA product code SAB (Table Mounted Miniaturized Electromechanical Surgical System). FDA's definition for product code SAB reads: "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...". FDA records list one 510(k) clearance for Virtual Incision. As of , FDA records show no recalls naming DEN230025.

Clearance record

Decision date
Received
(318 days to decision)
Product code
SAB Table Mounted Miniaturized Electromechanical Surgical System
Regulation
21 CFR 878.4962
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Virtual Incision 2125 Transformation Dr., Lincoln NE
Third party review
No

Clearances, product code SAB

Trailing 12 months
1 clearance under product code SAB in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SAB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260