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

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.

Global Registration Data
Multi-Country Intelligence
Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field
General, Plastic Surgery Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

SDD

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Class 2

21 CFR 878.4965

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General, Plastic Surgery

Device Characteristics

No

No

No

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.