Cleared Traditional

K242368 - Symani Surgical System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242368 · Medical Microinstruments, Inc. · General & Plastic Surgery device
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Feb 2025
Decision
182d
Days
Class 2
Risk

K242368 is an FDA 510(k) clearance for the Symani Surgical System. Classified as Electromechanical System For Open Microsurgery (product code SAQ), Class II - Special Controls.

Submitted by Medical Microinstruments, Inc. (Pisa, IT). The FDA issued a Cleared decision on February 7, 2025 after a review of 182 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4963 - 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.

View all Medical Microinstruments, Inc. devices

Submission Details

510(k) Number K242368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2024
Decision Date February 07, 2025
Days to Decision 182 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
68d slower than avg
Panel avg: 114d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SAQ Electromechanical System For Open Microsurgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4963
Definition An Electromechanical System For Open Microsurgery Is A Software-controlled Electromechanical System With Bedside Human/device Interfaces And Without An Integrated Visualization System Which Allows A Qualified User To Perform Surgical Techniques During Open Mircosurgical Procedures Using Surgical Instruments Attached To An Electromechanical Arm.
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.

Regulatory Peers - SAQ Electromechanical System For Open Microsurgery

Devices cleared under the same product code (SAQ) and FDA review panel - the closest regulatory comparables to K242368.
Symani Surgical System
K252287 · Medical Microinstruments, Inc. · Nov 2025
Symani Surgical System
K251510 · Medical Microinstruments, Inc. · Sep 2025
Symani Surgical System (820-03830)
K250014 · Medical Microinstruments, Inc. · Jan 2025
Symani Surgical System
DEN230032 · Mmi North America, Inc. · Apr 2024