FDA Product Code SAQ: Electromechanical System For Open Microsurgery
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.
Leading manufacturers include Medical Microinstruments, Inc. and Mmi North America, Inc..
FDA 510(k) Cleared Electromechanical System For Open Microsurgery Devices (Product Code SAQ)
About Product Code SAQ - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code SAQ since 2024, with 4 receiving FDA clearance (average review time: 155 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under SAQ have taken an average of 107 days to reach a decision - down from 346 days historically, suggesting improved FDA processing for this classification.
SAQ devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →