FDA product code SDD

Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field

General, Plastic Surgery·Class 2·21 CFR 878.4965
US regulatory classifications
US Product Code (FDA)
SDD
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.4965
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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 surgical system with transient sterile field presence of both surgeon and primary control interface is a software-controlled electromechanical system with fully positionable patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures. The device allows for both the surgeon and primary control interface to have presence inside the sterile field as needed within the clinical context of use.

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About this record

Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field 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.