Cleared Traditional

K260817 - MIRA Surgical System

K260817 is an FDA 510(k) clearance for MIRA Surgical System, manufactured by Virtual Incision. The device is a Class 2 General & Plastic Surgery device with product code SAB cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K260817 · Virtual Incision · General & Plastic Surgery device
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Aug 2026
Decision
160d
Days
Class 2
Risk

K260817 is an FDA 510(k) clearance for the MIRA Surgical System. Classified as Table Mounted Miniaturized Electromechanical Surgical System (product code SAB), Class II - Special Controls.

Submitted by Virtual Incision (Lincoln, US). The FDA issued a Cleared decision on August 20, 2026 after a review of 160 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4962 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K260817

510(k) Number K260817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2026
Decision Date August 20, 2026
Days to Decision 160 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 115d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

SAB Device Classification - Class 2, Special Controls

Product Code SAB Table Mounted Miniaturized Electromechanical Surgical System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4962
Definition 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 Device’s Miniaturized And Compact Size Allows The Effective Element Of The System To Be Inserted Into The Body Cavity And Use Surgical Instruments Attached To The Electromechanical Arms
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.