FDA product code SAQ

Electromechanical System For Open Microsurgery

General, Plastic Surgery·Class 2·21 CFR 878.4963
US regulatory classifications
US Product Code (FDA)
SAQ
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.4963
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Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Electromechanical System For Open Microsurgery is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.