Cleared Special

K250014 - Symani Surgical System (820-03830) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K250014 · Medical Microinstruments, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
25d
Days
Class 2
Risk

K250014 is an FDA 510(k) clearance for the Symani Surgical System (820-03830). 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 January 27, 2025 after a review of 25 days - a notably fast clearance 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medical Microinstruments, Inc. devices

Submission Details

510(k) Number K250014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2025
Decision Date January 27, 2025
Days to Decision 25 days
Submission Type Special
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
89d faster than avg
Panel avg: 114d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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.