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SAQ

Electromechanical System For Open Microsurgery

Product code
SAQ
Device name
Electromechanical System For Open Microsurgery
Device class
Class 2
21 CFR
21 CFR 878.4963
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
510(k) clearances (last 3 years)
5

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (5)

Last three years. Most recent: 2025-11-10.

NumberDecision dateApplicantDevice nameSummary
K2522872025-11-10Medical Microinstruments, Inc.Symani Surgical SystemPDF
K2515102025-09-04Medical Microinstruments, Inc.Symani Surgical SystemPDF
K2423682025-02-07Medical Microinstruments, Inc.Symani Surgical SystemPDF
K2500142025-01-27Medical Microinstruments, Inc.Symani Surgical System (820-03830)PDF
DEN2300322024-04-05Mmi North America, Inc.Symani Surgical System—

4 summaries are archived here for direct download.

Official FDA classification page: SAQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).